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S. Hrg.

107210

FOOD SAFETY AND SECURITY: CAN OUR FRAC-


TURED FOOD SAFETY SYSTEM RISE TO THE
CHALLENGE?

HEARING

BEFORE THE

OVERSIGHT OF GOVERNMENT MANAGEMENT,


RESTRUCTURING, AND THE DISTRICT OF COLUMBIA
SUBCOMMITTEE
OF THE

COMMITTEE ON
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION

OCTOBER 10, 2001

Printed for the use of the Committee on Governmental Affairs

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COMMITTEE ON GOVERNMENTAL AFFAIRS
JOSEPH I. LIEBERMAN, Connecticut, Chairman
CARL LEVIN, Michigan FRED THOMPSON, Tennessee
DANIEL K. AKAKA, Hawaii TED STEVENS, Alaska
RICHARD J. DURBIN, Illinois SUSAN M. COLLINS, Maine
ROBERT G. TORRICELLI, New Jersey GEORGE V. VOINOVICH, Ohio
MAX CLELAND, Georgia PETE V. DOMENICI, New Mexico
THOMAS R. CARPER, Delaware THAD COCHRAN, Mississippi
JEAN CARNAHAN, Missouri ROBERT F. BENNETT, Utah
MARK DAYTON, Minnesota JIM BUNNING, Kentucky
JOYCE A. RECHTSCHAFFEN, Staff Director and Counsel
HANNAH S. SISTARE, Minority Staff Director and Counsel
DARLA D. CASSELL, Chief Clerk

SUBCOMMITTEE ON OVERSIGHT OF GOVERNMENT MANAGEMENT,


RESTRUCTURING, AND THE DISTRICT OF COLUMBIA
RICHARD J. DURBIN, Illinois, Chairman
DANIEL K. AKAKA, Hawaii GEORGE V. VOINOVICH, Ohio
ROBERT G. TORRICELLI, New Jersey TED STEVENS, Alaska
THOMAS R. CARPER, Delaware SUSAN M. COLLINS, Maine
JEAN CARNAHAN, Missouri PETE V. DOMENICI, New Mexico
MARK DAYTON, Minnesota THAD COCHRAN, Mississippi
MARIANNE CLIFFORD UPTON, Staff Director and Chief Counsel
ANDREW RICHARDSON, Minority Staff Director
JULIE L. VINCENT, Chief Clerk

(II)

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CONTENTS

Page
Opening statements:
Senator Durbin ................................................................................................. 1
Senator Voinovich ............................................................................................. 23

WITNESSES

WEDNESDAY, OCTOBER 10, 2001


Robert A. Robinson, Managing Director, accompanied by Keith W. Oleson,
Assistant Director, Natural Resources and the Environment, U.S. General
Accounting Office ................................................................................................. 4
Hon. Rose L. DeLauro, a Representative in Congress from the State of Con-
necticut .................................................................................................................. 7
Hon. Elsa Murano, Ph.D., Under Secretary of Agriculture for Food Safety,
U.S. Department of Agriculture .......................................................................... 10
Bernard Schwetz, Ph.D., D.V.M., Acting Principal Deputy Commissioner,
Food and Drug Administration, U.S. Department of Health and Human
Services, accompanied by Joseph A. Levitt, Director, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, U.S. Department
of Health and Human Services ........................................................................... 13
Hon. Dan Glickman, Akin, Gump, Strauss, Hauer & Feld, L.L.P., former
Secretary of Agriculture, U.S. Department of Agriculture ............................... 15
Michael F. Jacobson, Ph.D., Executive Director, Center for Science in the
Public Interest ...................................................................................................... 27
John Cady, President and Chief Executive Officer, National Food Processors
Association ............................................................................................................ 28
Peter Chalk, Ph.D., Policy Analyst, RAND Corporation ...................................... 30
C. Manly Molpus, President and Chief Executive Officer, Grocery Manufac-
turers of America ................................................................................................. 31
Tim Hammonds, President and Chief Executive Officer, Food Marketing Insti-
tute ........................................................................................................................ 33

ALPHABETICAL LIST OF WITNESSES


Cady, John:
Testimony .......................................................................................................... 28
Prepared statement .......................................................................................... 108
Chalk, Peter, Ph.D.:
Testimony .......................................................................................................... 30
Prepared statement .......................................................................................... 113
DeLauro, Hon. Rose L:
Testimony .......................................................................................................... 7
Prepared statement .......................................................................................... 66
Glickman, Hon. Dan:
Testimony .......................................................................................................... 15
Prepared statement .......................................................................................... 94
Hammonds, Tim:
Testimony .......................................................................................................... 33
Prepared statement with an attachment ....................................................... 138
Jacobson, Michael F., Ph.D.:
Testimony .......................................................................................................... 27
Prepared statement .......................................................................................... 100
Molpus, C. Manly:
Testimony .......................................................................................................... 31
Prepared statement .......................................................................................... 127
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IV
Page
Murano, Hon. Elsa, Ph.D.:
Testimony .......................................................................................................... 10
Prepared statement .......................................................................................... 68
Robinson, Robert A.:
Testimony .......................................................................................................... 4
Prepared statement .......................................................................................... 45
Schwetz, Bernard, Ph.D., D.V.M.:
Testimony .......................................................................................................... 13
Prepared statement .......................................................................................... 74

APPENDIX
United Food and Commercial Workers International Union (UFCW), prepared
statement .............................................................................................................. 149

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FOOD SAFETY AND SECURITY: CAN OUR
FRACTURED FOOD SAFETY SYSTEM RISE
TO THE CHALLENGE?

WEDNESDAY, OCTOBER 10, 2001

U.S. SENATE,
OVERSIGHT
OF GOVERNMENT MANAGEMENT,
RESTRUCTURING, AND THE DISTRICT OF COLUMBIA,
OF THE COMMITTEE ON GOVERNMENTAL AFFAIRS,
Washington, DC.
The Subcommittee met, pursuant to notice, at 1 p.m., in room
SD342, Dirksen Senate Office Building, Hon. Richard Durbin,
Chairman of the Subcommittee, presiding.
Present: Senators Durbin and Voinovich.

OPENING STATEMENT OF SENATOR DURBIN


Senator DURBIN. This hearing will come to order. I thank you all
for coming today to discuss issues of food safety and security. Some
of my colleagues are running a little bit late. This has been an un-
usual morning because we had a memorial service for Senator
Mike Mansfield. Most of us have just gotten off the buses and
many of my colleagues had to quickly return to their offices. They
will be joining us in a few minutes. They are running a little bit
late, but I thank you all for coming today.
The hearing will come to order and good afternoon. I am pleased
to welcome you to this hearing of the Senate Subcommittee on the
Oversight of Government Management. We are going to focus on
food safety and security and the question: Can our fractured food
safety system rise to todays challenge? Let me say at the outset
and will say repeatedlywe have the safest food supply in the
world. That is something that bears repeating, because even
though we are raising questions about how to improve the system,
we start off with a food supply that is second to none. The question
which we are going to be asking ourselves today is whether or not
we can improve the system.
For many years now, I have worked on this issue, of food safety
focusing on questions which involve hazards in food that are natu-
rally occurring that can be avoided with appropriate inspection and
processing. In the last several weeks this conversation has
changed. It is no longer just about food safety. It is about food secu-
rity, and that is one of the aspects which we also have to take into
account. That is one of the reasons why I wanted to bring this
group together today.
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Our government structure divides responsibility for food safety


and security between at least a dozen Federal agencies operating
under 35 different Federal statutes. It is a system of divided re-
sponsibility. It is a system of rivalry, in some aspects, when it
should be one of cooperation. It is duplicative, it is costly and it is
unduly complicated. It is impossible to explain. In an age where
our Nations food supply is facing tremendous pressure from emerg-
ing pathogens to an ever-growing volume of food imports, from
changing food consumption patterns to an aging population suscep-
tible to food-related illness and even potential food security risks,
we must have a system in place to ensure the safety of our food.
Now is the time to fundamentally set the course for a food safety
system that is not only more efficient and effective, but one based
on science, with the promise of sustaining the confidence of the
consuming public. It is time for our government to have a single
food safety agency. I do not believe there is a person in this room
or in this city or this Nation that would say to us today that if they
had to invent a food safety system, they would invent what we
have in place.
Make no mistake, as I said, our country is blessed with safe and
abundant food supplies, but we can do better. Foodborne illness is
a significant problem. While food may never be completely free of
risk, we have to strive to make our food as safe as possible. Ameri-
cans at every level, Federal, State and local, industry and the con-
suming public, share this responsibility. The Center for Disease
Control estimates that as many as 76 million Americans will suffer
food poisoning this year. Of those individuals, 325,000 will be hos-
pitalized, and more than 5,000 will die. Children and the elderly
are especially vulnerable.
In terms of medical costs and productivity losses, foodborne ill-
nesses cost the Nation billions of dollars annually. The situation is
not going to improve without decisive action. In fact, the Depart-
ment of Health and Human Services predicts that foodborne ill-
nesses and deaths will increase 10 to 15 percent over the next dec-
ade from natural hazards. Over the past 25 years, the GAO and
other organizations, including the National Academy of Sciences,
have issued report after report describing the problems with Fed-
eral food safety oversight and the need for a single food agency.
These organizations have made many recommendations for change.
I think it is time we make that fundamental lasting change that
GAO has asked for. We need that single food agency. I introduced
the Safe Food Act of 2001 last week. It combines the functions of
USDAs Food Safety and Inspection Service, the FDAs Center for
Food Safety and Applied Nutrition, FDAs Center for Veterinary
Medicine, the Department of Commerces seafood inspection pro-
gram, and the food safety functions of several other Federal agen-
cies. This new agency will be funded by the combined budgets of
the consolidated agencies.
Following the events of September 11, we are more keenly fo-
cused on how varied aspects of Americas homeland security, in-
cluding our Nations food supply, may be vulnerable to attack. Our
Federal food safety system must be able to prevent potential food
hazards from reaching the public. We must establish procedures on
the farm and during the various stages of food processing to ensure

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that no form of deliberate contamination reaches consumers. We


also have to critically examine our import procedures to determine
if they are adequate to protect the public from food-safety threats.
A single food agency will help ensure that we have a cohesive proc-
ess in place.
Last night, I met with David Byrne, who is the Health and Con-
sumer Products Commissioner for the European Union. He is a
man I met several years ago at a St. Patricks Day parade in Chi-
cagohe reminded me of that. He is trying at this point in time
to establish this type of agency for the European Union. Now is the
time for us to start that dialogue with the European Union, to con-
tinue a dialogue that may have started before, but in more earnest
and sincere terms. As we look around the world to those countries
which seek to import from the United States and export to our
country, we have to establish some meaningful, scientific, reason-
able standards, so that we know the product that is moving across
the border is safe for everyone.
Overlapping jurisdictions of Federal agencies have really less-
ened accountability. A single agency focuses our policy and im-
proves our enforcement. Let me just say that research could be bet-
ter coordinated, as well, with a single agency. Currently Federal
funding for food safety research is spread over more than a dozen
different Federal agencies, and coordination is very limited. New
technologies to improve food safety could be approved more rapidly
with one food safety agency. Currently, food safety technologies
must go through multiple agencies for approval, often adding years
of delay.
With the incidence of food recalls on the rise, it is important to
move beyond short-term solutions. A single agency could more eas-
ily work toward long-term solutions. In this era of limited budgets,
it is our responsibility to modernize and streamline the system.
This Subcommittee has been discussing the weaknesses of the Fed-
eral food safety system for decades. I have not been here in that
discussion for decades, but it has been going on that long. It is time
to move forward. Lets stop discussing the need and actually make
it happen. I am encouraging my colleagues on both sides of the
aisle to help me to consolidate the food safety and security func-
tions.
At this point I was going to recognize Congresswoman Rosa
DeLauro, who I understand is on the way and may be here momen-
tarily. When she does, I am going to invite her to come up and
speak and interrupt the panel that may be speaking at the time
I hope everyone will understandbecause of her schedule. Let me
at this point welcome our first panel then. Robert Robinson is the
Managing Director of Natural Resources and Environment with the
U.S. General Accounting Office. He is accompanied by Keith
Oleson, who is the Assistant Director of GAOs Natural Resources
and Environment Division. Thank you for being here. We look for-
ward to your testimony. It is customary for the Subcommittee to
swear in all of our witnesses. So, if you would not mind standing,
do you swear that the testimony you are about to give is the whole
truth, and nothing but the truth, so help you, God?
Mr. ROBINSON. Yes, sir.
Mr. OLESON. Yes, sir.

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Senator DURBIN. Thank you very much. Let me note for the
record that the witnesses answered in the affirmative. Please, if
you could limit your oral statements so that we can follow up with
some questions
Mr. Robinson.

TESTIMONY OF ROBERT ROBINSON,1 MANAGING DIRECTOR,


ACCOMPANIED BY KEITH W. OLESON, ASSISTANT DIRECTOR,
NATURAL RESOURCES AND THE ENVIRONMENT, U.S. GEN-
ERAL ACCOUNTING OFFICE
Mr. ROBINSON. Thank you, Mr. Chairman, for this opportunity to
weigh in on this matter of real national importance. As you know
and have just mentioned, GAO has long called for the establish-
ment of a single food safety agency responsible for implementing
uniform and risk-based food safety legislation. I am here today to
renew this call.
While we believe the case for such action has been compelling for
some time, recent tragic events and the increased threats these ac-
tions portend for the future make the need for action all the more
imperative. While the American food supply is generally safe, the
5,000 deaths and millions of illnesses attributed to foodborne
pathogens each year provide ample evidence that the system needs
improvement. The current regulatory system did not emerge from
a comprehensive design, but rather was cobbled together piecemeal
over many years. The patchwork that now exists hampers efforts
to adequately address existing and emerging food safety threats,
whether those risks involved inadvertent or deliberate contamina-
tion.
It has also led to an inefficient and inflexible deployment of re-
sources, as well as inconsistent oversight and enforcement of prod-
ucts with comparable risk. With respect to resources, the current
deployment is not particularly rational and certainly is not risk-
based. FSIS and USDA spends about 70 percent of the Federal food
safety regulatory dollar inspecting on a daily basis about 6,000
meat, poultry and egg establishments that collectively produce
about 20 percent of federally-regulated foods. FDA, on the other
hand, has less than half of FSISs funding to oversee about 10
times more food production facilities and about four times more
federally-regulated foods.
In this context, the resulting oversight of food production is quite
inconsistent. Over the years, as I am sure you are aware, we have
used a number of food items, including canned soup and frozen
pizza, to put a specific face on the systems of irrationality. This
time we will use a packaged sandwich. As you can see from our
graphic, if you are producing a packaged open-faced meat or poul-
try sandwich, you get inspected daily by FSIS. If, on the other
hand
Senator DURBIN. Part of the Department of Agriculture?
Mr. ROBINSON. Yes. If, on the other hand, you are producing a
closed-face sandwich with identical ingredients, you get inspected
by FDA on average once every 5 years.
1 The prepared statement of Mr. Robinson appears in the Appendix on page 45.

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The current fragmented structure also has implications for food


imports, an area of growing importance to our food supply. FSIS
and FDA employ vastly different approaches. On the one hand,
meat and poultry cannot be exported to the United States unless
FSIS has determined that the exporting country has an equivalent
food safety system. This allows FSIS to leverage its inspection re-
sources. Also, until FSIS approves the release of imported products,
they generally must be kept in a registered warehouse. Unlike
FSIS, however, FDA does not have authority to require equivalency
agreements and is thereby forced to rely on widely discredited port-
of-entry inspections. Also, because FDA does not control imported
foods prior to its approval for release, some adulterated imports
have been released into U.S. commerce.
Now, of course, overhanging these long-standing limitations in
the current food safety system is the prospect of deliberate terrorist
contamination. The likelihood of such an attack is unknown. In a
recent report we identified only two acts of deliberate food supply
contamination over the past 15 years. However, based on the na-
ture of our food system and the weaknesses we have already identi-
fied, we believe there is reason to doubt our systems ability to de-
tect and quickly respond to an orchestrated bioterrorist attack. The
U.S. food distribution system moves food from production to mar-
kets in hours. Even if contamination was detected by the extremely
limited testing that occurs, vast amounts could already be in the
hands of consumers. Furthermore, even if the current surveillance
system worked as intended, the problem would not be typically
identified until multiple illnesses were reported.
Our fragmented system would compound these inherent difficul-
ties; for example, determining which Federal agency was respon-
sible for responding could take precious time when speedy action
would be absolutely essential. Similarly, split responsibility could
impede timely laboratory testing and the ability to marshal the full
range of Federal resources. Mr. Chairman, as you have mentioned,
while no system can be foolproof, the fragmented system now in
place is simply not good enough. A single food safety agency is
needed now more than ever. In this regard, we are gratified to note
that consolidation of food safety activities is supported by the Na-
tional Academy of Sciences, the Presidents Council on Food Safety
and a large number of former food safety officials. It is also con-
sistent with the recent actions taken by a number of other nations,
including Canada, Great Britain, Denmark, and Ireland.
Before concluding, I also want to make you aware of related work
that you may find useful. This work was performed by us in 1998
when we issued a classified report to the full Committee that laid
out the vulnerability of U.S. agriculture to a biological attack. We
have updated that work and have prepared a classified briefing.
The team is here and can present the information in a closed envi-
ronment whenever called upon.
Thank you.
Senator DURBIN. Thanks, Mr. Robinson, and I will take you up
on that, which, of course, will not be today, but we will do it in a
different setting. You made reference to U.S. Department of Agri-
culture. Our former Secretary is here and many of us have worked
with that Department and think very highly of it. I have equally

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high regard for the Food and Drug Administration. Many people
argue that we are dealing with two different cultures between
these agencies, in terms of the way they look at their responsi-
bility. As the GAO took a look at food inspection, did you note any
differences in approach or application of science or different cul-
tures?
Mr. ROBINSON. Well, differences in approach are pretty much
across the board, and a lot of it has to do with different legislative
authorities and requirements. Practically on every front, the au-
thorities are different and, hence, the approaches almost nec-
essarily are different. You could pretty much go down the line and
identify those differences.
Senator DURBIN. Lets get down to basics. Some argue that the
U.S. Department of Agriculture, because it has a responsibility to
promote the products, consumption and the like, is not in a good
position to be a watchdog over the agencies and the Department
the facilities and the businesses that it regulates through this in-
spection, whereas FDA takes a much different approach when it
comes to approvals for medical devices and pharmaceuticals and
the like. Did you note that in the GAO review of this process?
Mr. ROBINSON. Yes. This goes to the basic rationale that finally
led us to conclude that an independent agency was the way to go.
USDA fundamentally has the FAA problem. The same agency that
is responsible for promoting the industry is also responsible for reg-
ulating the safety of the product, obviously conflicting interests.
FDA, on the other hand, has a situation where the bulk of its re-
sources have usually been devoted to the D part of the agency,
leaving the F part of the agency in somewhat more of a stepchild
environment when resource allocations decisions were to be made.
So there is a fundamental
Senator DURBIN. When I took a look at this issue to try to deter-
mine how we can move from where we are today to a single food
agency, it was really tough to find a lot of parallels. The closest I
could find was the creation of the Environmental Protection Agen-
cy, where we took a lot of different agencies and brought them to-
gether under one roof with one mission, and if I am not mistaken,
it also involved a transition period before the EPA could really
open its doors and get down to business. Do you have any thoughts
on that aspect, moving from where we are today to a single food
agency? Have you seen any examples in other countries where they
have tried to accomplish this?
Mr. ROBINSON. Yes, a few years ago we did joint work with our
Canadian Office of Auditor General counterparts. We issued a joint
report with them on food import controls, and that report led the
Canadians to take action. They have moved pretty aggressively or
much more aggressively than we have to establish a single food
safety agency and although early, the signs seem to be positive. As
I mentioned in my statement, the British have moved in that direc-
tion, as have other Nations and the EU is now considering it, as
you mentioned.
I think the arguments are so compellingthe inefficiencies and
the gaps and the overlaps are so obvious it almost raises the ques-
tion as to what is holding the move to rationality back. There

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seems to be growing conceptual agreement on the basic decision of


consolidation. What remains to be worked out is the details.
Senator DURBIN. There are three things holding us back. I can
tell you what they are: One is Congress, where committees have ju-
risdiction and do not want to give it up; the other would be the
agencies currently involved that are fearful of losing jurisdiction;
and the third are people who are regulated. They are fearful of
change. You put those three together and you can explain why for
30 or 40 years this grand idea has gone nowhere. Maybe the events
of September 11 will give us the impetus to change.
One last question before I recognize my friend, Congresswoman
DeLauro. You made a reference to the international aspect of this
and clearly that is something we have to take into account, and you
noted that the FDA, aside from random border inspection, frankly
does not do much by way of inspecting food production overseas; is
that correct?
Mr. ROBINSON. Yes. I think currently it is about 1 percent of im-
ports under their jurisdiction are inspected. With additional re-
sources that have been requested, that percentage could rise a few
points. But essentially you have to ask yourself if raising that in-
spection level from 1 percent to 3 percentit does not move you
a lot further down the road; whereas I think leveraging resources,
like FSIS is allowed to do, to ensure that foreign nations that will
be the source of our food imports have installed systems com-
parable to ours and are implementing those systems based on test-
ing, is a far more efficient way, and I think, ultimately much more
effective and a more confidence-inducing way of proceeding.
Senator DURBIN. Well, I have taken a big enough task, dealing
with trying to consolidate our domestic food safety inspection, but
I really believe, as I said at the outset, that this should be dis-
cussed in a global context. As we are talking about our allies now
who are struggling against terrorism worldwide, I think we can
find the same type of alliances when it comes to food safety and
security, so that trade can continue with peace of mind. My con-
versations yesterday with the European Union led me to believe
that they are ready for this, as well. It not only will help us when
it comes to food safety and security, but in trying to find some com-
mon ground and resolution to many other intractable food safety
issues between the EU and the United States. I hope that will be
part of it.
If I could ask you and Mr. Oleson to just stay where you are for
a moment, I am going to turn over the microphone to my friend,
Congresswoman DeLauro, who has been a leader on this issue in
the House. Thank you for coming.
TESTIMONY OF HON. ROSA L. DELAURO,1 A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF CONNECTICUT
Ms. DELAURO. Thank you so very much, Mr. Chairman and my
good friend. I apologize to my colleagues at the table. I will try to
be brief. I would just like to say to my colleague, the Chairman,
Senator Durbin, that it has been an honor and a pleasure to work
with him. I sat on the Agricultural Appropriations Committee
1 The prepared statement of Ms. DeLauro appears in the Appendix on page 66.

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when Senator Durbin was the chair over there. This is an issue in
which he has really taken such a leadership role, and I am pleased
that we are going to continue to work on this effort, and I am
grateful to hear about your conversations with the European Union
as to what we might be doing with our allies overseas.
Our Nations food safety is of critical importance, we all agree
with that. The Center for Disease Control and Prevention says that
each year 76 million people get sick and 5,000 people die from a
food-related illness. I had a personal experience with this problem.
When I was a child I contracted Salmonella. I was hospitalized for
almost 2 weeks. I was so young that I did not know why my par-
ents had put me into this situation, away from them and so forth,
and I am told, though I do not remember, that I refused to talk
to them when I did get out of the hospital.
The numbers are staggering nationwide, of people getting sick
and people who are dying, and they do not include a vast number
of unreported illnesses. The situation is not going to improve with-
out some decisive action. Also, in terms of what happened on Sep-
tember 11, we need to be concerned about the safety of our food
from a bioterrorist attack. According to Raymond Zilinskas, who is
a senior scientist with the Monterey Institute of International
Studies, the most likely scenario for a biological weapons attack
would be foodborne or beverageborne attack, using Salmonella,
Shigella, or Staphylococcal toxins.
Tommy Thompson, the Secretary of Health and Human Services,
on October 3 submitted a request to OMB for additional money for
bioterrorism programs. In addition to other priorities, he identified
food safety as a vital area that needs to be addressed. The Sec-
retary has requested money for 200 imported food inspectors and
100 domestic food inspectors. I might add that several months ago
on the debate on this years agricultural appropriation, I offered an
amendment, which would have provided $90 million for 1,600 FDA
inspectors for imported food and $73 million for 630 domestic in-
spectors. It was defeated, but I think now more than ever we have
to go back to that effort.
Clearly, what we need is to have a comprehensive strategy, a
unified strategy. There are several agencies with different and con-
flicting missions that ensure our food safety. There is no standard-
ization for inspections. Processed food facilities may see an FDA in-
spector once every 5 to 6 years. Meat and poultry is inspected
daily. We need to do something. Everyone here is agreeing.
In 1998 the National Academy of Sciences study concluded that,
A model food safety system would have a unified mission, a single
official who is responsible for food safety at the Federal level and
who has the authority and the resources to implement science-
based policy and all Federal activities related to food safety. It
makes sense in order to protect our food supply to consolidate food
safety activities into a single agency. I introduced the legislation in
the House of Representatives, like my colleague on the Senate side.
It establishes that independent agency with responsibility for all
Federal food safety activities. It would transfer food safety inspec-
tion and food labeling activities to a new agency from the several
agencies that now are engaged in that process.

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We have 32 co-sponsors of the legislation. It is bipartisan. People


understand that this is the direction that we need to move in. This
is just plain good government, in my view. I might also add, in his
campaign President Bush publicly supported the idea of uniting all
food safety responsibility under one agency. On June 9, he said in
Philadelphia, The Federal Government is responsible for the safe-
ty of our Nations food supply. The way things work now, there is
one agency that inspects cheese pizza. There is another that in-
spects pepperoni pizza. There is one agency that inspects food
grown outside of the United States, another for food grown here in-
side the United States. Apparently the revolutionary idea that
maybe these functions could be combined has not dawned on any-
body yet.
It is time to create a 21st Century approach to our food safety
system, particularly because we have got this problem in the
United States, but globalization, aging population, faster produc-
tion, distribution of food increases people being at risk. I thank you
for the opportunity to have me here today to testify. This is good
common sense. I look forward to working with my colleague on
this. I thank you again for your leadership and I thank you for let-
ting me cut into the line.
Senator DURBIN. Congresswoman DeLauro, thank you and I
know your beeper went off, so you are going to have to make a mad
dash. I would just say that the one thing that we have to step back
and doso many times now on Capitol Hillis say if terrorism dis-
appeared tomorrow and our prayers were answered, would this still
be a good idea? I think the answer is clearly yes, but terrorism has
not disappeared and we have to put it into the equation now. I
think it really adds an element of immediacy to this debate and
perhaps it will move us off dead center, where we have been too
long. Thank you for your leadership in the House. You are excused.
Thank you very much.
Mr. Robinson, I understand that some of the people who have
headed up these agencies in the past at FSIS and FDA, once liber-
ated from government service, have announced that they always
thought this was a pretty good idea. Have you run into that?
Mr. ROBINSON. We have obviously done some exploration with in-
dividuals and touched base with eight or ten folks, and I think is
a pretty clear consensus, as I mentioned earlier, that conceptually,
consolidation makes all the sense in the world and it ought to be
pursued aggressively.
I do want to make the point, though, it is not just consolidation
of bureaucracies. You have 35 laws, as you mentioned, out there
that also need to be rationalized. The basis for a lot of action is leg-
islative in nature, and that is going to have to be addressed to
make a single food safety agency realize the promise that so many
of us believe it can.
Senator DURBIN. Thank you.
Mr. Oleson, is there anything you would like to add?
Mr. OLESON. The individuals we contacted, former administra-
tors of FSIS and former commissioners of FDA, former Under Sec-
retary of Agriculture, former Secretary of Agriculture, all concur
that consolidation needs to take place and they all agree that one
thing that should be consolidated is the inspection activities, at

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least. There are some differences after we get past that on what
should be included, but inspection is one you can start with, as
your bill clearly recognizes, Senator.
Senator DURBIN. Good. I appreciate both of you coming today.
Thank you very much for your testimony and continued work.
Maybe before GAO does another couple dozen reports making this
recommendation, Congress will actually do something.
Mr. ROBINSON. Well, the paper on the 1992 report, our first one
on the subject, is starting to yellow. [Laughter.]
Senator DURBIN. Thanks for joining us. We appreciate it.
Mr. ROBINSON. We will be in contact with your staff relative to
the classified briefing.
Senator DURBIN. Thank you very much.
I want to welcome our next panel: Dr. Elsa Murano, the recently
confirmed Under Secretary of Agriculture for Food Safety, thank
you very much for being with us today; Dr. Bernard Schwetz, who
is the Acting Principal Deputy Commissioner of the Food and Drug
Administration with the U.S. Department of Health and Human
Services; accompanied by Joseph Levitt, the Director for the Center
for Food Safety and Applied Nutrition from the U.S. Department
of Health and Human Services; and a good friend, former colleague
and a great public servant, Dan Glickman, former Secretary of Ag-
riculture, who is now in private practice with Akin, Gump, Strauss,
Hauer, and Feld. I want to make sure to announce that so, when
you get back, your partners will forgive you for the time you have
given us this day.
As I said earlier, it is customary to swear in the witnesses, and
I hope you will please stand and allow me to administer the oath.
Do you swear the testimony you are about to give is the whole
truth, and nothing but the truth, so help you, God?
Ms. MURANO. I do.
Mr. SCHWETZ. I do.
Secretary GLICKMAN. I do.
Senator DURBIN. The record will indicate the witnesses answered
in the affirmative, and I would ask you to, if you would, please give
5-minute opening statements, and your whole statement will be
submitted for the record.
Dr. Murano, would you be kind enough to start?

TESTIMONY OF HON. ELSA MURANO, PH.D.,1 UNDER SEC-


RETARY OF AGRICULTURE FOR FOOD SAFETY, U.S. DEPART-
MENT OF AGRICULTURE
Ms. MURANO. Mr. Chairman and Members of the Subcommittee,
I appreciate the opportunity to appear at todays hearing and dis-
cuss our Nations food safety system and structure. I am Dr. Elsa
Murano, Under Secretary for Food Safety at the U.S. Department
of Agriculture. As you know, I am a newcomer to USDA, having
just been confirmed as Under Secretary on September 26, and I
was sworn in October 2. I am honored to be serving in this impor-
tant position and I am committed to the hard work ahead. I know
there are many important food safety issues before the Congress,
1 The prepared statement of Ms. Murano appears in the Appendix on page 68.

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and I look forward to working closely with you to make progress


on those issues.
I have been a researcher and teacher in the field of food safety.
My research efforts have led me to investigate pathogens such as
E. coli O157:H7, Listeria Monocytogenes, and Salmonella. I believe
my experience as a scientist and educator and my perspectives as
an outsider looking in will be valuable as I begin this new position.
FSISs mission is to ensure that the Nations commercial supply of
meat, poultry and egg products is safe, wholesome and correctly la-
beled and packaged. FSISs goal is to protect the public health by
significantly reducing the prevalence of foodborne hazards in meat,
poultry and egg products. FSIS has a long, proud history of pro-
tecting the public health, dating back to 1906.
Although changes have been made over the years to the inspec-
tion program, the most dramatic change occurred when FSIS pub-
lished a Pathogen Reduction/Hazard Analysis and Critical Control
PointHACCPsystems rule in 1996. Under HACCP, industry is
accountable for producing safe food. Government is responsible for
setting appropriate food safety standards, maintaining vigorous in-
spections to ensure those standards are met, and maintaining a
strong enforcement program to deal with plants that do not meet
regulatory standards.
Our food safety system is being challenged by many factors. They
include emerging pathogens, an increase in international trade,
new food products in the marketplace, a growing segment of the
population at greater risk of contracting foodborne illnesses and
gaps in education all along the farm-to-table chain. On September
19 the Bush Administration published its review of the food and
agricultural system with a view toward identifying critical needs
for the next century. The report, titled Food and Agricultural Pol-
icy, Taking Stock for the New Century, details the enormous
changes that have taken place in food and agriculture. Food safety
certainly is a vital part of food and farm policy, and the report em-
phasizes this.
I would like to provide more details today about two key areas
of the food safety infrastructure and the importance of integrated
food safety programs. Let me begin with the USDA food safety in-
frastructure. Inspection of meat, poultry and egg products is an im-
portant part of that infrastructure. FSIS currently has approxi-
mately 10,000 employees, the bulk of which are stationed in the
field. More than 7,600 inspection personnel are stationed in ap-
proximately 6,000 meat, poultry, and egg plants. FSIS also certifies
foreign programs as possessing public health safeguards that are
equivalent to the U.S. program and reinspects imported product as
it enters the United States.
FSIS is also responsible for assessing State inspection programs
that regulate meat and poultry products that may be sold only
within the State in which they are produced. There are currently
27 states that have a State meat or poultry inspection program and
operate under cooperative agreements with FSIS. Another part of
the FSIS food safety program involves its three multidisciplinary
laboratories, which conduct laboratory testing for microbiological
contamination, chemical and animal drug residues, pathological

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conditions, processed product composition, and economic adultera-


tion.
FSIS also conducts compliance and enforcement activities to ad-
dress situations where unsafe, unwholesome or inaccurately-la-
beled products have been produced or shipped. Surveillance is an-
other part of the infrastructure. A strong food safety system must
have a mechanism for identifying new food safety problems rapidly.
USDA conducts surveillance of the food supply and HHS Centers
for Disease Control and Prevention, in partnership with State and
local health departments, conducts surveillance for human food-
borne illness.
Outbreak responses is also key. Because coordination is essen-
tial, we have taken steps to expedite communication during large,
multistate outbreaks. One mechanism is the Foodborne Outbreak
Response Coordinating Group, FORCG, a partnership established
to better respond to interstate outbreaks of foodborne illness.
USDA, HHS and EPA formed this partnership. This interagency
group has coordinated and developed procedures for managing out-
breaks, sharing information on potential sources of outbreaks and
pathogens, and coordinating interdepartmental activities.
A similar group, the Food Emergency Rapid Response and Eval-
uation Team, FERRET, has been established within USDA to co-
ordinate the activities of USDA agencies. USDA participates in
PulseNET, a national network of public health laboratories sup-
ported by HHS. These laboratories aid outbreak response by per-
forming DNA fingerprinting of foodborne bacteria and comparing
results through an electronic database maintained by CDC.
Research is another important part of the food safety infrastruc-
ture. FSIS is not a research agency, but works through the Agricul-
tural Research Service to meet its research needs. Risk assessment
is another important part of the food safety infrastructure. You can
never completely eliminate foodborne health hazards, and re-
sources are limited. Risk assessments help us to set priorities.
Education also figures prominently. Partnerships have been key
in education. The Fight Bac campaign is sponsored by the Partner-
ship for Food Safety Education, a public-private partnership with
participation from USDA, HHS, and the States. I provided you
folders containing some of the outreach and educational materials
we use in the food safety education campaign. There are even a
couple of brochures in Spanish, Mr. Chairman, that you may enjoy.
Like every infrastructure, the food safety system requires peri-
odic review, ongoing reinforcement and appropriate modernization
just to keep pace with continuously emerging and often unique
challenges. What has become very clear is that the services USDA
provides, from eliminating foodborne pathogens to protecting
against plant and animal pests and diseases to encouraging farm
practices that stress conservationall are interrelated and must
continue to be carefully and comprehensively coordinated. We can
do more to examine whether Federal food safety agencies can im-
prove the services they provide, but this should be done by a care-
ful step-by-step process and by continued coordination with other
agencies involved in the food safety system.

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Mr. Chairman, thank you again for this opportunity to discuss


our Nations food safety system and structure, and I look forward
to any questions you may have.
Senator DURBIN. Thanks, Dr. Murano. I will have some ques-
tions. Dr. Schwetz, from the FDA.
TESTIMONY OF BERNARD SCHWETZ, PH.D., D.V.M.,1 ACTING
PRINCIPAL DEPUTY COMMISSIONER, FOOD AND DRUG AD-
MINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES, ACCOMPANIED BY JOSEPH LEVITT, DIRECTOR,
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. SCHWETZ. Good afternoon, Mr. Chairman. I am Bernard
Schwetz, the Acting Principal Deputy Commissioner of the Food
and Drug Administration. I am appearing here today on behalf of
the Department of Health and Human Services. Thank you for this
opportunity to discuss the Federal food safety system. Ensuring the
safety of the food supply is a top priority for HHS. I am pleased
to be here today with my colleague from USDA, Dr. Elsa Murano,
Under Secretary for Food Safety.
The American food supply does continue to be the strongest and
the safest in the world. Great strides have been made in recent
years that have strengthened the Federal food safety system. The
Federal food safety program includes new surveillance systems,
better prevention programs, faster outbreak response, enhanced
education and better coordinated and focused research and risk-as-
sessment activities. Food safety agencies are working more closely
together than ever before, but our world is constantly changing and
we must continue to change with it. Indeed, we cannot rest until
we have built a strong and credible food safety system that ad-
dresses the full range of food safety issues, one that is built on sci-
entific expertise, that is risk-based and recognizes and responds to
new risks, that provides a critical inspection presence, that has the
same level of protection to consumers from both domestic and im-
ported foods, that efficiently stewards new technologies to the mar-
ket and that effectively educates and communicates with con-
sumers.
Within HHS, the Food and Drug Administration has jurisdiction
over 80 percent of domestic and imported foods that are marketed
in interstate commerce. This jurisdiction includes all food products
except meat, poultry, and egg products, which are regulated by
USDA. FDA seeks to ensure that foods are safe, sanitary, nutri-
tious, wholesome, and properly labeled. HHSs Center for Disease
Control and Prevention has an important complementary public
health role. As the lead Federal agency for conducting disease sur-
veillance, CDC monitors the occurrence of illness in the United
States attributable to the food supply.
The disease surveillance systems coordinated by CDC are an es-
sential information network for providing early warnings about
dangers in the food supply, for demonstrating progress in reducing
foodborne illness and for indicating new or changing patterns of
foodborne illness. Both the FDA and CDC work closely with our
1 The prepared statement of Dr. Schwetz appears in the Appendix on page 74.

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Federal food safety partners and with State and local health food
safety officials.
While the current system is working, the system needs to be
strengthened to address the current challenges. The goal of HHS
is to work with our Federal and State partners as well as with aca-
demia, industry, consumer organizations and Congress, to build on
the current foundation, resulting in a strong and credible food safe-
ty system that addresses the full range of food safety issues. The
system has three simple steps: To identify risks, to take action, and
to measure results.
In identifying risks we must ensure a strong science base, which
is the foundation of any successful food safety system. We must
also develop, enhance, and maintain surveillance systems that can
quickly and accurately identify food safety risks in human food and
animal feed supplies and manage disease risks effectively. These
surveillance systems are the key to an effective emergency re-
sponse capability.
In taking action we must start with prevention. We need strong
risk-based prevention standards to prevent contamination of all
human foods and animal feeds over the farm-to-table continuum.
As these risk-based standards are developed, we need education
and training programs so that those in the industry and the public
can effectively utilize them to reduce the risk of illness. In addition,
domestic inspections of the food industry are essential to ensure
that the appropriate preventive controls are implemented.
While FDA uses a risk-based system to prioritize its inspections
and now inspects firms that produce high-risk foods on an annual
basis, we still need to provide more frequent coverage for all the
firms. For imported food, we need a strong inspection and moni-
toring program to ensure that imported foods meet the same level
of protection as domestic foods. For both domestic and imported
food, we need to maintain an adequate enforcement program to be
sure the rules are followed. We also need science-based methods to
measure results so we know how we are doing. When implemented,
the framework I have just described would minimize foodborne ill-
ness and injury, maximize consumer confidence and enhance global
competitiveness.
As food may be a medium for spreading infectious diseases, let
me address the Departments approach to the challenges of bioter-
rorism. The broad goals of a national response to bioterrorism are
to detect the problem, control the spread of the epidemic, and treat
the victims. Our approach to this challenge has been to strengthen
public health infrastructure to deal more effectively with epidemics
and other emergencies, and to hone our emergency health and
medical response capacities at the Federal, State and local level.
We have also worked to forge new partnerships with organizations
related to national security. Our efforts have been focused on im-
proving the Nations public health surveillance network to quickly
detect and identify the biological agent that has been released,
strengthening the capacities for medical response, especially at the
local level, expanding research on disease agents that might be re-
leased, developing new and more rapid methods for identifying bio-
logical agents, and improve treatments and vaccines and improving
information and communication systems, among other activities.

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Thank you for this opportunity to discuss our food safety pro-
gram. HHS appreciates your continued interest and leadership in
improving food safety. I look forward to working with you and the
Subcommittee on ways to continue to improve the safety of the Na-
tions food supply. I would be happy to answer questions.
Senator DURBIN. Thank you, Dr. Schwetz. Secretary Glickman.

TESTIMONY OF HON. DAN GLICKMAN, AKIN, GUMP, STRAUSS,


HAUER, AND FELD, L.L.P.1 FORMER SECRETARY OF AGRI-
CULTURE, U.S. DEPARTMENT OF AGRICULTURE
Secretary GLICKMAN. Thank you. I am one of those liberated
souls thatspeaking for myself. But it is a pleasure to be before
this Subcommittee and my senior statesman, Senator Durbin, a
great leader. Let me just say that I agree with the statement that
we have the safest food in the world, and our safety system is the
best in the world, and part of that is due to the very talented work-
force at FSIS and APHIS and the Agriculture Marketing Service
people in the FDA and the other agencies, and I also would say
things are better coordinated now than they were 10 years ago
among the various agencies.
But if the current system did not exist and we started from
scratch to put it together, it would not look like it does now. We
would not design it that way. We would make some structural
changes. I believe the United States needs fundamental organiza-
tional change in the way the Federal Government handles food
safety. After working on these issues both in the House, as a House
member from Kansas, and as Secretary, during that 6-year period
when Federal food regulation underwent the most significant
changes in a century and faced some of its most severe tests, par-
ticularly in the courts, I have concluded that the basic structure is
flawed and needs rebuilding.
Senator Durbin, I commend you for doggedly pursuing this prob-
lem, and appreciate the opportunity. In my statement I start out
with a few things about Federal food safety statutes now. These
are substantive statutes. I am not going to repeat them. They are
in the statements, but things like we have called for before, for ex-
ample, the ability for the government to level civil penalties, the
ability for USDA and FDA to order recalls which are not there.
There is a need for FDA and USDA to have the authority to act
against food when epidemiological evidence links it to disease, not
just in those instances when the food is infected with pathogens.
We need a lot more resources, particularly in the FDA, to do its
business, and FDA needs an adequate food manufacturing data-
base. Currently, USDA knows where meat and poultry is processed
because of Federal recordkeeping requirements. The FDA does not
have complementary information. So all these things, many of
which continue to build on what others have said, I think need to
be mentioned, because notwithstanding what we do with organiza-
tion and restructuring the Federal Government, the substantive
laws need to be strengthened to give the government appropriate
authority to do its jobs.
1 The prepared statement of Secretary Glickman appears in the Appendix on page 94.

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But on the regulatory structure, one of the lessons we learned


during the Clinton Administration was, short of outright organiza-
tional changes the need for much greater coordination across food
safety-related agencies was a high priority, and that led to a num-
ber of interagency entities, the Presidents Council on Food Safety,
a Joint Institute for Food Safety Research, and other items. While
all of these efforts vastly improve the overall Federal response to
this problem, they suffer fundamental flaws that a consolidated
Federal regulatory agency would remedy. First and foremost is the
central control of resources.
While joint planning, communication and coordination facilitate
a united response to food safety, at the end of the day, unless con-
trol over spending is vested in a single authority, there will remain
bureaucratic and institutional obstacles to achieving the ends that
we want to achieve. A unified centralized structure brings with it
another asset, a central decisionmaking entity who is in charge,
who is accountable for the probleman example is the Starlink
episode. The Starlink corn episode, while not probably a traditional
food safety issue, it highlights that flaw.
Most strikingly, many questioned the initial wisdom of a split
registration for this particular product, and the ability of the sys-
tem to keep the corn in separate segregated marketing channels,
one for animals and one for human consumption. Regrettably,
those deficiencies were realized in what happened. Now, fortu-
nately we have not seen that kind of problem in the magnitude on
the human side of the picture, but we have seen it in a variety of
animal-related issues, and it could have easily happened here.
I have long felt that while we went through the process in the
Clinton Administration of improving coordination and dealing with
some of the substantive issues, that we did not want to let a heated
debate over reforming the structure interfere with our primary
goal. I urged a go-slow approach to organizational revision during
the period of enormous food safety change that we went through
in the last 8 years. I did not want to either divert the attention
from the reform process, nor permit disagreements over structure
to stop that.
But the fact of the matter is that the time is now, to bring these
functions together, and I am confident a successful rationalization
of the Federal food safety regulatory structure will require bold
strokes. A piecemeal approach will leave us essentially where we
are, with a fragmented, and duplicative system.
Now, finally I might make a couple of comments about terrorism
and related threats. As we look at the threat from chemical or bio-
logical attack or other terrorist threats, too frequently agriculture
and food received scant attention. We got a wake-up call last
month, not only from the savage viciousness of the attack, but also
from the new kind of threats we face. For example, the grounding
of the Nations fleet of crop dusters drove that point home.
While at USDA, we launched a multiagency review of agri-
cultures exposure to non-conventional threats. Without revealing
the specific threats, nor the steps we are taking to protect our-
selves, let me simply state that the problem is immense, as are the
consequences and the effort we need to protect from it. Consider
again the Starlink episode, which I referred to. That is a telling

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lesson of how quickly and pervasively an undesired product can


contaminate our food supply, or consider a few years ago when
Karnal Bunt first infested this country. To eradicate this wheat
fungus, we prevented the farmers from whose land the infected
wheat originated from planting wheat at all for 3 years.
The point these episodes illustrate is that even comparatively be-
nign contaminants to our food supply can spread dramatically, es-
pecially given the size and concentration in much of our food dis-
tribution and processing, and may need profound and long-lasting
steps to recover. I should point out that while agents such as botu-
lism or anthrax affecting food and water get a lot of attention,
media attentionAmerican agriculture could also be gravely
threatened by outbreaks of more traditional problems like foot-and-
mouth disease and BSE.
The solution partially lies with reform structures and organiza-
tional changes. It also partly lies with good statutory authority
given to the agenciesfair statutory authorityand I am confident
that you will do that. In closing, let me repeat the three points I
want to emphasize with you: One, we need to reorganize and con-
solidate our Federal food safety regulators; two, we need just as ur-
gently to make improvements to our underlying food safety stat-
utes; and, third, an integrated food safety regulatory structure is
critical to meeting the new challenges of terrorism we face.
All of this is needed to ensure our highest priority, which is con-
tinued public confidence in the safety of our food system, which is
the linchpin of both our public health, as well as the economic
health of American agriculture.
Thank you, Mr. Chairman.
Senator DURBIN. Thank you, Secretary Glickman. Let me start
with some questions.
Dr. Schwetz, you said at one pointI do not know exactly, but
paraphrasing youwe should view food as a medium for bioter-
rorism. I think that is really one of the elements that underlies this
hearing today. Can you give me a description of how food could be
a medium for bioterrorism?
Dr. SCHWETZ. Well, yes, I would be happy to do that, Mr. Chair-
man. What I really do not want to do is talk in any detail that
would provide
Senator DURBIN. No, I do not want you to.
Dr. SCHWETZ [continuing]. A roadmap for people to do things
that we do not want to have happen. But because we have an agri-
cultural process that produces a lot of food, either from the United
States or imports from outside the United States that is distributed
widely, common food items that we either import and consume as
they are, or foods that are processed within the United States,
there are a relatively small number of food that represent a large
part of what we consume, and it would be possible for one of those
to become the medium of some agent that would be distributed
that would accomplish what a terrorist might want to do, is to
reach a large number of people relatively quickly through some
means that they would not necessarily expect there to be a prob-
lem.
Senator DURBIN. Dr. Murano, our lives have all changed since
September 11 at every level, governmental and personal. How have

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18

things changed in the outlook of your agency at the U.S. Depart-


ment of Agriculture, FSIS, and other food safety inspection since
September 11?
Ms. MURANO. Well, Mr. Chairman, I think September 11
changed everybody. Let me begin by saying that. At the agency we
took a hard look, and are right now taking a hard look at what sys-
tems we have in place and how to improve upon them. Thankfully,
we have 7,600 inspectors inspecting meat and poultry in every
plant in the United States. Having them in place as a matter of
our standard operating procedures, gives us an advantage, as a
public health agency, which is what FSIS really is.
We are about food safety, and what we do is inspect these prod-
ucts to try to prevent to the greatest extent possible any foodborne
outbreaks, which is one of the main goals of the agency. We can
always do better, and I assure you, again without really saying too
much as far as details, that we are looking at what other ways we
can improve our system. Certainly the entities that I mentioned in
my testimony, FORCG and FERRET, have been crucial for us to
be able to ascertain how to better coordinate activities, not only
within USDA, but also with our partner in health, HHS.
Senator DURBIN. Let me follow up on that, and just staying with
the food security aspects that we have now raised since September
11, and without asking for any detail for the same reason that Dr.
Schwetz mentioned, has there been a gathering of the various food
safety inspection agencies at the Federal level, of all the different
agencies, to sit down and to try to map out a common strategy to
protect the security of Americas food supplies since September 11?
Ms. MURANO. Let me answer that, Mr. Chairman, by saying that
as soon as I was confirmed, we had a meeting of FERRET, which
are agencies within USDA that have to do with food emergency
rapid response. We are working right now with our partners in
HHS to get FORCG to look at what its charter is, what it is doing,
the activities that it has done in the past and how we can improve
those. We have meetings scheduled very soon, and we have had
conversations with our partners at HHS to pursue these avenues.
So I assure you that we are extremely cognizant of the fact that,
now more than everand I agree with the words that you said at
the beginning of this sessionat this time of war, we have to work
together.
Senator DURBIN. Have there been special meetings called since
September 11 of these agencies, to talk about food security?
Ms. MURANO. Yes, sir.
Senator DURBIN. Is there more evidence of cooperation among
these agencies?
Ms. MURANO. I can safely tell you yes, and perhaps one of the
reasons is a simple reasonwell, two reasons. The one I just stated
is the fact that this emergency has brought us together as Ameri-
cans and certainly has elevated the importance of these issues and
has made us want to work together more than ever. Second, be-
cause there are a lot of new faces, not just mine. When you have
a lot of new faces, people perhaps do not have the past histories
of animosity that might preclude reaching over and meeting each
other. So we have been able to get together very well and very
quickly.

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Senator DURBIN. Have you talked about coordinating inspec-


tions? We know there is such a wide variety of inspection stand-
ards when it comes to food at the Federal level. Since September
11, have you addressed that possibility of coordinating these in-
spections?
Ms. MURANO. It is one of the issues that we are discussing.
Senator DURBIN. Dr. Schwetz, same question. Since September
11, what has happened in terms of the food security issue at FDA
and what has happened in terms of your relationship with other
agencies?
Dr. SCHWETZ. I would reinforce what has already been said, that
we have had meetings between a number of Federal agencies, even
going beyond HHS and USDA, to bring agencies together to discuss
what are the areas where we need to be communicating more effec-
tively to deal with these kinds of issues, where are weaknesses that
we have where resources need to be put now to strengthen
Senator DURBIN. Can you tell us any of those weaknesses that
we might address at the congressional level? Is there a need for
some funding that is readily apparent to you, in light of September
11, where we should look at it immediately?
Dr. SCHWETZ. They are matters of the proper legislation and au-
thority to be able to do the kinds of things that we have limits to
now, and some of them have already been discussed.
Senator DURBIN. Can you give us examples?
Dr. SCHWETZ. The ability to hold product once we have a sus-
picion that something might be wrong, civil money penalties to a
greater extent than we have worked out these arrangements with
Customs and other agencies and with States. So there are some
legislative changes that need to be made, but primarily the vulner-
ability of the FDA is not having enough people to be able to man
the spots that we need to have covered, to have the inspectors, to
have the laboratory capabilities to back up the sampling that would
follow questions of terrorist action. So between resources and legis-
lation, those are two major areas.
Senator DURBIN. Secretary Glickman raised an important point.
I want to ask him a question about it directly, but about the whole
question of the authority to withhold food product based on epide-
miological concerns, as opposed to pathogens. Is that another ele-
ment or another area where you see need for legislative change?
Dr. SCHWETZ. Yes, that would be.
Senator DURBIN. So at this moment in time, if we suspected or
even knew that there was a source of food in the United States
that posed a danger because of bioterrorism or epidemiological con-
tamination, does the FDA or the USDA, have the authority to take
that product off the market?
Dr. SCHWETZ. I cannot answer that exactly, but I would assure
you that we would look between the Federal agencies, between
USDA, between Customs, whatever authorities we have collec-
tively, we would work as hard as we could to keep that from
spreading.
Senator DURBIN. I am sure you would. Anyone in good conscience
would, but clearly Members of Congress, in good conscience, need
to give you the clear authority to do it.
Dr. SCHWETZ. Yes.

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Senator DURBIN. Secretary Glickman, that is a point that I think


we ought to spend a moment on. But your belief now is that the
current law does not empower the agencies to do this? Though they
might find some way to do it, it is not a clear delegation of author-
ity.
Secretary GLICKMAN. At best, it is unclear, and USDA was spe-
cifically challenged in this, in one particular instance, where we did
not have complete success, let me say. You might find some general
authority under some welfare clause provision of the Constitution
or some other agency, FEMA or somebody, but I do not believe it
is clear.
Senator DURBIN. Well, so that we understand this for the record,
should we everand God forbid that we dorun into a situation
of biological contamination, acts of bioterrorism on the food supply,
it is your understandingand I believe that the other witnesses
are in agreementthat we do not have the statutory authority at
this moment to remove product from market, off the shelves, away
from consumers, absent some specific change in the law?
Secretary GLICKMAN. I do not believe so. I think that probably,
if you had a national emergency with bioterrorism, we would find
it somewhere. But I do not think we have it clearly enough to deal
with the non-terrorist problem, and therefore we would not nec-
essarily be able to jump to the terrorist problem.
Ms. MURANO. Mr. Chairman, may I interject a little bit here?
Senator DURBIN. Sure, Dr. Murano.
Ms. MURANO. As you probably know, FSIS has the authority to
seize and detain products. So that is a very important authority
that we do have, and that certainly is one of the ways that one can
stop an outbreak from spreading any further.
Senator DURBIN. And let me ask you to follow up on that. Sec-
retary Glickman made note of the fact that the USDA needs au-
thority to recall food from the market. You were talking about stop-
ping and detaining the delivery, but recalling food from the market
is not in your list of current authorities; is that right?
Dr. SCHWETZ. That is correct.
Senator DURBIN. Is that your understanding, Dr. Murano?
Ms. MURANO. That is correct. I would say food safety is the pri-
mary issue, obviously, with my colleagues at HHS and certainly
with the Food Safety and Inspection Service. When there is an out-
break situation, recalling product as rapidly as possible is ex-
tremely important. I think we all agree with that. The real ques-
tion, I suppose, is who should have the responsibility to do that?
That is something worth exploring, and I think that is what the
Secretary is alluding to.
Secretary GLICKMAN. Mr. Chairman, I would just say most com-
panies, in my experience, would voluntarily and cooperatively work
this issue, but because of mass communication and dissemination
of food, and the logistics problems, you could imagine a cir-
cumstance, even if a cooperative company would be involved in
doing it, you could not get the food fast enough back into the hands
of either the government or the company itself.
Senator DURBIN. So we have two things that have come out so
far, and one is the use of these epidemiological standards for the
monitoring of the food supply, something clearly that needs to be

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21

done, and, second, the ability to recall the product clearly in the
law, where there is a national issue or urgency involved in it.
Those two things seem very clear.
Now, Secretary Glickman, you also talked about the imposition
of fines, and what are you alluding to there?
Secretary GLICKMAN. Well, right now I would say the Depart-
ment of Agriculture has the ultimate penalty, the nuclear bomb, so
to speak, because what it can doit could withdraw the mark of
inspection. It can close a factory down, which is obviously a critical
power. But, in some cases, you want to move more creatively and
quickly without having to shut a factory down, without having to
cause people to lose their jobs, and civil penalties are not within
the ambit of USDAs authority, as they are in the Consumer Prod-
uct Safety Commission and, I believe, other agencies.
Senator DURBIN. Dr. Murano, you made the point that you are
brand-new and, in that respect, have newer faces and less baggage
and less of a history. Your background is in science, I take it?
Ms. MURANO. Yes, sir. I am a scientist.
Senator DURBIN. As you take a look at the Federal laws involv-
ing food safety and inspection, do you see that common scientific
thread that weaves through these 12 different agencies and 35 dif-
ferent laws?
Ms. MURANO. Well, Mr. Chairman, certainly if you are asking me
common sense science, I am not going to go there.
Senator DURBIN. No one is going to go there based on common
sense.
Ms. MURANO. But let me say that I think we all recognize that
using science as the basis for what we do for food protection is the
goal that we want to achieve, and risk assessment within the risk
analysis system is one way to achieve it, as I discussed in my open-
ing remarks. Following that thought, I would like to say again that
because food safety is our goal and what FSIS does, because it is
a public health agency, anything that would improve the safety of
our food supply is something that we are interested in doing.
I would like to say one more thing regarding recalls. In exploring
this issue, we have to obviously think about whose responsibility
it should be for our food supply. Should it be the responsibility of
the people who make it, or should it be the governments responsi-
bility? There are some extremely complex issues that are embedded
within that question. So it is something that we have to look at
very carefully.
Senator DURBIN. I am going to ask one semi-scientific question,
and forgive me, as a liberal arts lawyer, if I do not state it very
artfully, but, Dr. Schwetz, is there any mechanism in place now
where you can monitor contamination beyond the obvious Sal-
monella, E. coli, to those new threats that we are considering, the
bioterrorist threats? Are there ways to monitor these things?
Dr. SCHWETZ. Yes. The bacteriological and the other detection
procedures for being able to identify viruses and bacteria and other
organisms that might be included, those procedures are, for the
most part, available. Many of them have been used clinically for
many years. So the methods to identify those organisms are avail-
able for our use. We have adapted those so we can identify those
organisms in food or other places where they might come into con-

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22

tact with food. So the methods are available to identify the orga-
nisms.
Senator DURBIN. The last question I will ask of the three prin-
cipals on the panel goes to this culture between the FDA and the
USDA. This is a battle I have been witnessing for 20 years. Some-
times it is a friendly relationship and sometimes not so friendly,
but it appears that the two agencies really view their missions in
different terms, and one of the reasons we do not have a single food
agency is because there are those who just love the USDA and
every part of it and do not want to give up anything, on Capitol
Hill and the population at-large, and others who feel the same
about the FDA. But many argue that they really are two different
philosophies, two different cultures that come to this business of
food inspection. I would like to first ask Secretary Glickman, what
is your thought on that?
Secretary GLICKMAN. Well, Senator, I really do not think that is
as big a factor. I will tell you, after the Congress reorganized the
Department of Agriculture in 1994, you created a separate Food
Safety and Inspection Service and pulled it out of the marketing
and regulatory programs, basicallyI must tell you my experience
with those folks at FSIS led me to believe that they were among
the toughest government regulators that I saw, and people of high
integrity.
Now, the fact of the matter is they were officed in the same
building and basically were in the same venue with people who had
promotion functions, as well. I do not really think that is the crit-
ical problem here, because I think the system can kind of trudge
along probably all right with coordination the best you can. I just
do not think, given the modern world of pathogens and threats,
that you cannot do it very well without some sort of central ac-
countability there, and that is why I think this needs to be done.
I think in the old days, this may have been a problem. I really
do not think it is as much of a problem anymore.
Senator DURBIN. Dr. Schwetz, you have been at FDA for awhile.
What is your observation?
Dr. SCHWETZ. Yes, I have been with the FDA for a little over 8
years now, and my observation is that the working relationship is
far different today than it was 8 years ago. There are a number of
things that have happened in the past few years that have forced
us to work together more effectively than we ever did before, and
I think for the most part we have come to realize that we do have
partners in other agencies that we have to depend on, we have to
work with, for example, to keep things like BSE out of the country,
and foot-and-mouth disease. So the readiness plans that we have
developed, the science that we have shared, the people that we
have kind of moved back and forth to tap the intelligence that we
have between the agencies, there is a lot more of that today than
there ever has been.
Senator DURBIN. Dr. Murano, you are the new person in town,
but do you see a difference in the mission between the FDA and
your food safety responsibilities at USDA?
Ms. MURANO. Mr. Chairman, when I talk to my colleagues in
FDA who are scientists like myself, we are scientists and we have
the same view in terms of what we want to do to achieve a safer

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23

food supply. So, at that level, certainly I know that we have kin-
dred spirits. What we have to do is forget what the relationships
have been in the past. I know that probably sounds extremely
naive of me to say that, but I am going to give it my best and I
know my colleagues at HHS will, as well, because we are in a new
day. We are facing threats that we never imagined we would have
to be facing and we are committed to working together.
We are Americans. We have an incredible challenge ahead of us,
and we have to meet that challenge. This is the time to do it.
Senator DURBIN. Thank you very much. Senator Voinovich.
OPENING STATEMENT OF SENATOR VOINOVICH
Senator VOINOVICH. Thank you, Mr. Chairman, for holding this
hearing. This is the third hearing that I have participated in on
this subject of oversight of food safety, and I commend the Chair-
man for his long-standing interest in this area. I am not going to
go into my full opening statement, but I would like to say to you,
as a follow-up to this hearingI would like to request that the ad-
ministration witnesses submit for the record a comprehensive list
of all the Federal agencies involved in food safety, from the Animal
and Plant Health Inspection Service at the Department of Agri-
culture to the U.S. Customs Service, along with a description of the
function the agency serves, the current personnel levels at the
agency, the personnel needs of the agency in terms of both num-
bers and skills. I know that is not new information, because I know
from talking to Sean OKeefe allegedly that request has gone out
to various agencies about where they stand in terms of their per-
sonnel.
Senator VOINOVICH. It is my understanding the Food Safety In-
spection Service at the Department of Agriculture is working to at-
tract health inspectors with a stronger service background to im-
prove the agencys oversight. I think this kind of information would
be very useful to this Subcommittee in our deliberations.
In terms of questions, in the governmentwide high-risk area of
human capital management, GAO says the following about the De-
partment of Agriculture: Organizational cultural problems, includ-
ing resistance from the affected USDA agencies and employees,
have hampered department-wide reorganization and modernization
efforts. Further, the Nations food safety system, in which USDA
plays a major role, continues to suffer from inconsistent oversight,
poor coordination and inefficient deployment of services.
Do you feeland I am asking this of the administration wit-
nessdo you feel that the human capital management as it relates
to food safety oversight is an issue only at the Department of Agri-
culture, or does it span across various departments and agencies
involved in our Federal food safety oversight system? If the prob-
lem does include the entire food safety system, would a consolida-
tionthat is what this is all aboutwould a consolidation of food
safety oversight into one central agency improve this organization
culture that is resistant to change?
Ms. MURANO. I would like to answer that by saying I think we
all know that managing people is always a challenge, no matter
what organization you are talking about, whether it deals with food
safety or it does not deal with food safety. I am aware of great ef-

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forts that are taking place right now to modernize the workforce
of the Food Safety and Inspection Service. I have been very im-
pressed with the effort that these folks have begun already with
their new consumer safety officers, to bring a highly technically-
trained individual to inspection plants.
There are also efforts toand, in fact, right now there are epi-
demiologists on staff, as well, who are dispatched in cases where
there might be a foodborne illness outbreak suspected. So it is not,
I do not think, any more the perhaps-stereotypical view that people
have held over what inspectors are. We have extremely highly-
trained people and have worked really hard in that last few years
to modernize the workforce. There has been a reorganization at
FSIS to better serve or better accomplish the services that FSIS is
supposed to provide.
Is there room for improvement? Absolutely, there always is room
for improvement, and that is what I am here for, and that is what
the administrator at FSIS has as a top priority, because that is one
of the two things that FSIS does and does very wellinspect our
food supply in a way that is effective and in a way that is done
in a transparent way, and that is accountable. That is the key fea-
ture of any activity that one conducts. You must be accountable to
the people that you serve and to your superiors.
The second activity, of course, has to do with regulations, and to
base those on science is a key feature of FSIS as an agency. So I
think we need to start looking at what the agency has accom-
plished in the last few years under Secretary Glickman, who cer-
tainly has been witness to some of those planning activities, and
I am happy to tell you that those are being realized right now, even
as we speak.
Would better cooperation and some consolidation be a way to go?
We are very open to discussing any way that will improve the safe-
ty of our food supply, because that is our commitment.
Senator VOINOVICH. Well, the fact of the matter is that we have
been talking about thisthe Chairman of the Subcommittee, what,
you have been working on this for 20 years? We keep talking about
something is going to happen, and even though there are some
really good things that each agency is doing and we have a fine
system, I do not think it is where it ought to be. From a govern-
mental point of view, as I look at this organization, speaking as a
former mayor and governor, it is a crazy patchwork that does not
make sense and, to me, needs to be reorganized to get the job done,
to eliminate the duplication, take advantage of the strengths that
we have in the various departments and get the job for the public.
I know some of the industrial people are worried about it because
we will have some kind of a super-czar agency that might harass
them or whatever the case may be. But I would like you to tell me
if you have seen any better coordination in the last couple of years.
I think it has gotten to the point where you need to reorganize this
operation.
Mr. Schwetz, I would like your opinion. What do you think?
Dr. SCHWETZ. Our feeling is that reorganization by itself, Sen-
ator, is not going to make our food safety system a lot better than
it is today. We have already gained a lot of benefit in the last few
years by virtue of better funding, to be able to do the work which

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25

represents the underpinnings for a safer food supply. So there has


been a lot of progress made, and we think that even within the ex-
isting system more progress can continue to be made.
If the decision is made that there would be a single food agency,
it is not a matter of reorganization. The legislative underpinnings
to determine the authorities have to be redetermined. The right
kind of budget support has to be there to deal with the risks that
we would identify are the primary risks to deal with in the food
supply. So we have to have the right funding, we have to have the
right laws, we have to have the right kinds of expertise within that
agency or within our existing agencies to be able to deal with the
risks that we have.
One of the concerns that we have, also, is that even within a
large organization where you have an office of this and you have
an office of that, you still have different cultures between various
components of a large organization. So we would have to work aw-
fully hard to be sure that we do not have those same kinds of dif-
ferences between components of a new organization that we all cite
today as those examples at the margins of our organizations now
that make it look like we have two different approaches or two dif-
ferent people looking at the same problem. So reorganization by
itself is not going to be a simple thing and it will not be enough
to really
Senator VOINOVICH. Reorganization is never simple. I have been
through it several times in both capacities, but the issue is, have
we gotten to the point now where we need to do that? What do you
think of Chairman Durbins bill?
Senator DURBIN. Put him on the spot.
Senator VOINOVICH. What do you think about it? Is the adminis-
tration at all interested? Of course, they have got their hands full
right now. I am sure they are not thinking about this problem, but
where are we?
Dr. SCHWETZ. The new bills do address some of the problem, but
one of the difficulties that we recognize, for example, within the
Food and Drug Administration itself, is that we have certain com-
ponents of the agency that are specifically assigned to food safety,
but the way we are organized there are also parts of each one of
our components of the agency, that even though they might be as-
signed to drugs or to veterinary drugs or to other statutory authori-
ties, that still involves food safety. So it is very difficult to say that
this is the part of the FDA that deals with food safety, because
there is a large part of it that also deals with drugs, deals with de-
vices, and deals with biologics. They also have people who deal
with food safety issues. So that makes it very difficult to think
about how the Food and Drug Administration would work if the
food part of it was taken out and took out the research capabilities,
took out the field capabilities, all of which are shared between food
questions and questions of other products that we regulate. The
same question exists if you expand it between agencies.
Ms. MURANO. The administration has not taken a position on
this issue, but I would like to say again that my office is open to
discussion on this subject.
Senator VOINOVICH. Mr. Glickman, you have been there. What do
you have to say about it?

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Secretary GLICKMAN. I agree with you. I would say that, at a


minimum, budgets, planning and accountability for food safety
ought to be in one place. Now, the devil is always in the details.
I was just thinking as you were talking, the inspection functions
those of you who know the difficulties in the relationships between
inspectors and FSIS at USDA, and that has got a long history and
culture, know that that is a significantly different relationship than
certainly you have at FDA, where you hardly have any inspectors
at all. So, as you say, this has to be done very intelligently. It has
to be very inclusive in order to not create a revolution in the proc-
ess, but that should be no reason not to try to do it.
I think that is why I think somebody suggestedI think the
GAO suggested you start at the inspection, try to bring them to-
gether, because that is where the rubber hits the road in terms of
finding problem product. But I go back to this thing, there has got
to be some central budgeting and central accountability in this
process, as well. If you do not have it, then it is not worth any-
thing.
Senator DURBIN. Thank you very much. Let me ask one last
question of Dr. Murano and Dr. Schwetz. Since September 11,
there has been a heightened awareness of national security and a
lot of efforts to coordinate the U.S. response, and I am one who ap-
plauds Governor Ridge joining the administration in his new capac-
ity with the Homeland Defense Agency. But can you tell me wheth-
er or not either of your agencies, USDA and the FDA, have been
included in these national security briefings and discussions since
September 11?
Ms. MURANO. I can tell you, Mr. Chairman, that we are very
much included, and that is all I will say.
Senator DURBIN. OK. Dr. Schwetz.
Dr. SCHWETZ. Yes, we are also very much included with a lot of
the discussions that are going on between agencies and with the
National Security Council.
Senator DURBIN. Thank you. Thank you very much. I want to
thank this panel for the contribution they made today. We appre-
ciate you coming by.
I am now pleased to welcome the next panel and invite them to
come forward: Dr. Michael Jacobson, Executive Director of the Cen-
ter for Science in the Public Interest; John Cady, President and
Chief Executive Officer of the National Food Processors Associa-
tion; Dr. Peter Chalk, Policy Analyst with RAND Corporation;
Manly Molpus, President and Chief Executive Officer, Grocery
Manufacturers of America; and Tim Hammonds, President and
Chief Executive Officer, Food Marketing Institute.
Thank you all for coming. If you will remain standing behind
your appropriate name places, I will swear you in, as custom of the
Subcommittee. Please raise your right hand. Do you solemnly
swear to tell the truth, the whole truth, and nothing but the truth,
so help you, God?
Mr. CADY. Yes.
Mr. CHALK. Yes.
Mr. HAMMONDS. Yes.
Mr. JACOBSON. Yes.
Mr. MOLPUS. Yes.

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Senator DURBIN. Thank you very much. Let the record indicate
that the witnesses have answered in the affirmative.
Dr. Jacobson, would you be kind enough to begin?

TESTIMONY OF MICHAEL F. JACOBSON, PH.D.,1 EXECUTIVE


DIRECTOR, CENTER FOR SCIENCE IN THE PUBLIC INTEREST
Mr. JACOBSON. Thank you very much Senator Durbin. My name
is Michael Jacobson. I am the Executive Director of the Center for
Science in the Public Interest. CSPI is an education and advocacy
organization based in Washington that focuses on food safety and
nutrition. We are supported largely by the 800,000 subscribers to
our Nutrition Action Healthletter and by foundation grants.
As we have heard earlier, CDC estimates that contaminated food
causes 76 million illnesses and 5,000 deaths every year. Over the
past decade several notorious outbreaks of foodborne illness, named
after such companies as Jack-in-the-Box, Schwans, and Sara Lee,
have demonstrated that unintentionally-contaminated food is all
too common, all too deadly. More recently, the terrorist attack has
spurred widespread concern about intentional contamination of our
food supply and the governments ability to minimize that risk.
Those concerns are not unfounded. Last year, a CDC committee
warned that terrorists might try to contaminate our food supply
with such pathogens as clostridium botulinum, and E. coli
O157:H7.
The recent National Academy of Sciences report agreed, explain-
ing that biological agents could be produced quickly and inexpen-
sively. We saw how easily bacteria can be used as a weapon when
in 1984 members of a religious commune in Oregon contaminated
10 salad bars with Salmonella, sickening 751 people. Be it bioter-
rorism or sloppy manufacturers, we are relying on old laws to regu-
late new hazards. The Safe Food Act of 2001, introduced by Sen-
ator Durbin, offers a much-needed corrective to one of the major
defects in our Nations food safety system.
Food safety oversight is balkcanized among at least nine Federal
agencies, from the Department of Agriculture to the Bureau of Al-
cohol, Tobacco and Firearms. That fragmented responsibility, com-
pounded by inflexible statutory restrictions, results in many gaps,
inconsistencies and inefficiencies in government oversight. For ex-
ample, as we have heard many times over the past 5 or 10 years,
makers of pepperoni pizzas get inspected every day, while makers
of cheese pizzas get inspected only once every few years, even
though both kinds of pizzas pose similar risks, I had not learned
until today about open-faced versus closed-faced sandwiches, which
takes this issue to ludicrous heights.
Currently, the FDA, which has just 150 inspectors to ensure the
safety of four million shipments of imported food, inspects less than
1 percent of those shipments. Eggs, depending on whether they are
in the shell or processed, are overseen by either FDA or FSIS, and
a third agency grades them for quality. Meanwhile, no agency is
trying to prevent Salmonella contamination from ever happening
back on the farm.
1 The prepared statement of Mr. Jacobson appears in the Appendix on page 100.

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For crops that are genetically engineered to produce a pesticide,


the EPA evaluates the safety of the pesticidal chemical while the
FDA reviews the safety of the whole plant except for the pesticide.
EPAs process is open and mandatory, while the FDAs process is
secret and voluntary. Frankly, that kind of jury-rigged system is
nuts. Professor John Bailar of the University of Chicago, who au-
thored a paper published by the National Academy of Sciences,
concluded, Our country needs a single independent food safety
agency. When bioterrorism is added to the mix, the case for prompt
and sweeping change becomes compelling.
A sensible system, food safety system, would allow officials to de-
ploy resources when and where they are needed most. For instance,
judging from CSPIs database of foodborne-illness outbreaks, foods
regulated by the FDA caused four times as many outbreaks as do
foods regulated by USDA. However, the FDA has only about one-
tenth as many inspection personnel, and there is no way to trans-
fer inspectors from factories producing lower-risk canned beef stew
to packers distributing higher-risk fresh alfalfa sprouts. That mis-
match between risk and resources has led CSPI and other con-
sumer groups to call on Congress and the President to develop a
single coherent food safety statute that would be implemented by
a single independent food safety agency.
CSPI strongly supports the Safe Food Act of 2001, which, if
passed, would result in a major and long-needed upgrading of our
food safety system. We also would strongly support a parallel and
equally-essential effort to develop a unified food safety statute.
Thank you very much, Senator, both Senators, for your con-
tinuing leadership to improve food safety and for giving me the op-
portunity to offer CSPIs views.
Senator DURBIN. Thanks, Dr. Jacobson. Mr. Cady.
TESTIMONY OF JOHN CADY,1 PRESIDENT AND CHIEF EXECU-
TIVE OFFICER, NATIONAL FOOD PROCESSORS ASSOCIATION
Mr. CADY. Thank you, Mr. Chairman, for this opportunity to tes-
tify about our ability to ensure food security within the framework
of our current regulatory system. My written testimony, which I
will not read, outlines in greater detail our thoughts, not just on
this subject, but also on the broader issue of whether we need a
single food safety agency. I will make a few opening comments and
look forward to your questions, sir.
First, Mr. Chairman, I want to salute both you and the Ranking
Member and former Chairman of the Subcommittee, Senator
Voinovich, for your leadership on food safety issues. You have my
commitment to continue to work with you and the Subcommittee
on how we can best improve the management of our food safety
regulatory systems.
Mr. Chairman, the National Food Processors Association is the
Nations largest food-only trade association and its voice on sci-
entific, technical and regulatory issues involving food safety. There
are a lot of food-trade associations, as you know, which reflect the
great diversity and reach of our industry, but NFPAs focus has
long been on research, science, food safety, manufacturing practices
1 The prepared statement of Mr. Cady appears in the Appendix on page 108.

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29

and emergency situations for our 350-member food companies. We


have special expertise in the area of food security, which has long
been a top priority of our industry, specifically in the area of tam-
pering and contamination.
Mr. Chairman, we have great confidence in our food safety regu-
latory system for protecting the integrity of our food supply, both
for domestic and imported foods. We believe both Secretary
Veneman and Secretary Thompson and their respective agencies
have done an outstanding job of responding to the tragic events of
September 11. We are confident that they have worked closely with
their regulated industries to ensure that the systems are in place
to adequately address threats to our food supply. Through our asso-
ciation the industry has also created an alliance for food security,
which is coordinating the industrys efforts and communications
with Federal agencies.
We recognize that the food safety system is not perfect. We have
long advocated for more resources for the Food and Drug Adminis-
tration to ensure it can perform its core mission. In particular,
FDAs information tracking system for imported foods, called Oasis,
needs to be updated. More research to develop better sampling and
testing techniques are needed to get a more rapid response. We un-
derstand that the Bush Administration is advocating more inspec-
tors at our borders and ports to make sure that nothing slips
through, and I have been told that Governor Ridge will focus on
food safety and food security as part of the new Office of Homeland
Defense, where he will be looking at budgets and the need for new
legislative authorities.
Given the vast powers that FDA already has over imported foods,
we do not believe, however, that additional authorities at this time
are necessary, and any emergency regulatory actions taken during
this period of crisis should have sunset provisions considered. It is
also very important that we do nothing that has the unintended
consequence of lessening consumer confidence in our Nations food
supply. Our Nations outstanding food safety record has led to a
high and justified level of consumer confidence in our food supply.
It would do a serious disservice to consumers to send a message
that our food supply is unsafe, especially in light of the tragic
events of September 11 and the war in which we are now engaged.
We must all watch what we say, how we say it, and understand
that our words greatly impact the public.
On your proposal for a single food safety agency, Mr. Chairman,
we commend you for your thoughtful approach to a very difficult
issue, NFPA, however, is not yet prepared to endorse this proposal.
In fact, as I noted in our written statement, we believe all the ob-
jectives that you outlined in the bill can be achieved by better uti-
lizing existing authorities, starting with the Cabinet Secretaries, to
both coordinate and allocate resources and streamline overlaps in
jurisdiction before seeking any kind of new legislation. A new man-
agement layer, which I see a single food agency to be, is simply not
necessary at this time. Rather, we endorse a single food safety pol-
icy that would be implemented on a unified basis across the exist-
ing agencies.
Thank you, Mr. Chairman and Senator Voinovich, and I look for-
ward to your questions.

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Senator DURBIN. Thanks, Mr. Cady. Mr. Chalk.


TESTIMONY OF PETER CHALK, PH.D.,1 POLICY ANALYST, RAND
CORPORATION
Mr. CHALK. Mr. Chairman, and Members of the Subcommittee,
thank you very much for this opportunity to provide testimony on
this very important subject. I am a policy analyst at RAND who
has spent most of the last 10 years studying terrorism. The views
I will be presenting are my own and should in no way be reflected
as representing RAND or of any of the sponsors of its research.
Over the last 7 years considerable investments have been made
in infrastructure protection within the United States, and this has
led to an increasingly well protected infrastructure that now spans
the ambit from conventional bombings right through to more exotic
acts of biological terrorism. Agriculture, however, is one area where
not too much attention has been paid in this regard, and I would
suggest that this is problematic for two main reasons.
Agriculture is absolutely critical to the economic, social and polit-
ical stability of the United States. Certainly, in economic terms it
is of utmost importance. It is the countrys largest single employer,
$50 billion is raised every year through agricultural exports. Cattle
farmers and milk producers alone earn between $50 billion and $54
billion through meat and milk sales. The disruption of this highly
critical sector would cause a tidal economic wave effect that would
impact, not only on the sector itself, but also on the individual and
the consumer.
For a number of reasons, agriculture does remain vulnerable to
either deliberate acts of sabotage or indeed, to naturally occurring
outbreaks.
First, the disease susceptibility of animals in general has risen
as a result of biotechnic modifications that have served to lower the
natural disease resistance of animals to pathogens.
Second, there are many more diseases that are both highly con-
tagious and infectious to animals than is the case with human
beings. We know of at least 22 that currently exist. Most of these
are also environmentally hardy and many livestock are not rou-
tinely vaccinated against them.
Third, diseases tend to spread very quickly amongst animal pop-
ulations simply because of the intensive and concentrated nature
by which they are housed, bread and transported within the United
States. A typical dairy can be expected to have at least 1,500 lac-
tating cows, with some of the larger facilities having between 5,000
and 10,000 animals. Stopping an outbreak of a highly infectious
disease at any one of those facilities would be very difficult.
We also have a proliferation of food processorsparticularly at
the lower end or the smaller end of the scalethat lack adequate
internal quality control, may not have very viable product recall
plans; and also, largely do not undertake effective screening of sea-
sonal employees, which exacerbates the potential of insiders getting
in. I should have stress that this problem exists at the medium and
lower end of the scale. And finally, the increased production of ge-
netically modified foods has also increased the possibility of ex-
1 The prepared statement of Mr. Chalk appears in the Appendix on page 113.

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tremists and radicals carrying out acts of violence against GM


foods, and we have certainly seen aspects of that in Europe.
The impact of a major agricultural disaster in this country would
be enormous. Economically, we would have effects that could cross
at least three levels: Direct economic impacts resulting from con-
tainment procedures and eradication procedures; indirect economic
effects resulting from compensation paid to farmers who were af-
fected by the loss of their productsin the UK, the recent foot-and-
mouth disease outbreak has resulted in over $1 billion in com-
pensation costs alone being paid; and finally, international costs in
the form of protective trade embargos that are imposed by major
trade partners against the affected country, in this case, the United
States.
Beyond that we would also probably get a loss of political support
and confidence in government. A major agricultural disaster would
undoubtedly cause people to lose confidence in the food supply, and
it could also cause them to question the effectiveness of existing
WMD preparedness in general. In addition, the actual mechanics
of instituting a viable response to a major agricultural disaster
could elicit public criticism in the form of reaction to mass culling
and disposal operations.
Finally, we could have social instability as a result if an act led
to a major public health scare, and here we are talking about a
foodborne disease outbreak or the introduction of an animal disease
outbreak that is also zoonotic in its implications.
A number of areas do need to be substantially increased and en-
hanced in preparation for public infrastructure protection of agri-
culture. We need more diagnostic training. We need an overhaul of
the veterinarian curriculum with more emphasis given on large-
scale husbandry, better standardized links between the criminal
justice communities, intelligence communities and the USDA.
I do support your own suggestion here of instituting a single
agency to stream line and rationalize the oversight for food safety
within this country. Thank you very much.
Senator DURBIN. Thank you, Mr. Chalk. Mr. Molpus.

TESTIMONY OF C. MANLY MOLPUS,1 PRESIDENT AND CHIEF


EXECUTIVE OFFICER, GROCERY MANUFACTURERS OF
AMERICA
Mr. MOLPUS. Thank you, Mr. Chairman and Members of the
Subcommittee. I appreciate the opportunity to appear before you
this afternoon and compliment the Chairman and Members of the
Subcommittee for giving us this opportunity for an exchange of
views on the important issue of food safety. The testimony I am
providing this afternoon is endorsed by a number of additional food
trade organizations, specifically, the American Frozen Food Insti-
tute, the American Bakers Association, International Dairy Foods
Association, and the Snack Food Association.
GMA-member companies make and market the worlds best
known brands of foods and beverages around the world. Our mem-
bers represent approximately 90 percent of the branded food and
1 The prepared statement of Mr. Molpus appears in the Appendix on page 127.

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beverage products sold in the United States. So nothing is more


fundamental or has a higher priority for us than food safety.
The United States, as the Chairman indicated in his opening re-
marks, has the safest, most abundant and varied food supply in the
world. We have achieved this enviable position, not by luck or acci-
dent, but through the commitment of the food and agriculture in-
dustries and generations of dedicated public servants. The achieve-
ments of this partnership are reflected in the high confidence that
American consumers have in the safety of their food supply. Ac-
cording to the Gallup organization, 82 percent of consumers have
confidence that the Federal Government adequately ensures the
safety of food. That consumer confidence is not misplaced. We do,
in fact, have a remarkably good food safety record.
The system we have is not perfect however, and it can be en-
hanced, but before we embark on a radical restructuring of the food
safety regulatory system, we believe we should be absolutely con-
vinced that there is no better way to address the issues of concern.
During the Clinton Administration, the Presidents Council on Food
Safety studied this issue and concluded that, Reorganization by
itself will not significantly change the food safety systems capa-
bility to assure public health protection, and that, No single
structure for the food safety system provides a perfect solution.
Todays food safety system has evolved into a sophisticated
science-based system that appropriately allocates responsibility
among several Federal agencies. The allocation of responsibility
among multiple agencies is not inherently wrong or misguided.
Rather, it reflects the informed judgment of lawmakers and govern-
ment food safety officials over many decades that different sectors
of the food supply present different challenges and, thus, call for
different inspection expertise and different focus of regulatory re-
sources. When fundamentally different regulatory systems are
called for, dividing responsibility among agencies represents a log-
ical approach. In short, food safety regulation is not a one-size-fits-
all situation.
We should not underestimate the challenges that would be faced
in combining all food safety regulatory activities. From the experi-
ence of many of our member companies, it is difficult and disrup-
tive to implement a merger. Combining organizations inherently
means a period of uncertainty, distraction, loss of focus and effi-
ciency. Now, perhaps more than any time in our history, we need
to stay focused on the job at hand. Having said that, this does not
mean that we seek to maintain the status quo. There is room for
improvement of our current system and we have four recommenda-
tions.
First, consumers in the food industry are best served by strong
food safety agencies which develop policy based on sound science.
I would like to focus particularly on FDA. Although the responsibil-
ities of the FDA have increased dramatically over the last several
decades, the funds appropriated to FDA for its food safety-related
functions have failed to keep pace. GMA has already taken a lead-
ership role in this area. For some time we have provided leadership
to a food industry coalition whose objective is to increase the
awareness of more resources at FDA.

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We have at GMA a board-led task force of CEOs committed to


helping assure that the case for additional FDA resources is made.
For the past several years GMA has urged Congress to fully fund
increases in FDAs budget for food safety, and I think it is worth-
while mentioning today that the Congress, with the help of several
appropriators on the Subcommittee, including the Chairman, is
about to, for the first time, approve the FDAs full budget request.
Second, our food safety system must emphasize science and re-
search. We must identify and fight the true causes of foodborne ill-
ness with the right scientific weapons. Good science has always
been a critical component of sound food safety regulation, and it is
incumbent, therefore, on all of us with the shared commitment to
effective food safety regulations to think creatively about ways to
bring more science to FDA, and better scientists. We might do this
through a fellowship program, such as what doctors go through at
NIH and come out of NIH. We might have a fellowship program
bringing young scientists to FDA.
Third, collaboration, coordination and consultation should be a
full-time commitment for all our Federal and State regulators. The
Secretaries should make it absolutely clear as they carry out their
shared missions that their job is to eliminate duplications and inef-
ficiencies. A good example has been the joint agency work on food-
safety research.
Fourth and finally, one of the most dramatic changes that oc-
curred with regard to our food-safety supplies is the extent to
which we now have a global marketplace. FDA regulated products
enter the United States from more than 100 countries. We must
ensure that our regulatory agencies have more resources and tools
to effectively regulate imported products.
In conclusion, GMA and its member companies are firmly com-
mitted to the continued integrity and effectiveness of our food safe-
ty regulatory system. No one has a greater stake in the credibility
of the system than our member companies. We are open to consid-
ering a wide range of ideas and proposals to improve our current
systems. But before we scrap a system that is regarded as the best
in the world, we should fully explore strategies to enhance the sys-
tem through adequate funding, better coordination, the best
science, and continued innovation.
Thank you, Mr. Chairman.
Senator DURBIN. Thank you, Mr. Molpus. Mr. Hammonds.
TESTIMONY OF TIM HAMMONDS,1 PRESIDENT AND CHIEF
EXECUTIVE OFFICER, FOOD MARKETING INSTITUTE
Mr. HAMMONDS. Chairman Durbin and Senator Voinovich, thank
you for inviting me here today. My name is Tim Hammonds and
I am the president and CEO of the Food Marketing Institute. FMI
is the national trade association representing the retail super-
markets and food distribution industry. I will summarize here
today, but with your permission, will submit my full statement
along with FMIs board-adopted policy in support of designating a
single food agency for your record.
1 The prepared statement of Mr. Hammonds with an attachment appears in the Appendix on
page 138.

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In our view, this hearing is especially timely because our current


Federal food safety system is ill-equipped to deal with todays chal-
lenges. Clearly, no one now designing a regulatory system to main-
tain the wholesomeness and integrity of our food would ever design
anything remotely resembling what we have today. The case for
designating a single food agency, then centralizing resources and
responsibility, was compelling in May of the year 2001 when FMIs
board of directors adopted that position. The need for such a sys-
tem now is imperative.
We believe this could be accomplished without disturbing the
oversight authority of the current committees of jurisdiction in the
House and the Senate. You will note that we are on record in sup-
port of designating a single food agency, not in support of creating
an entirely new agency. We believe too much expertise would be
lost, too much of our existing credibility would be squandered, and
too much time would be wasted if we attempt to create an entirely
new agency from scratch. In our view, the best course of action
would be to centralize resources, responsibility and authority with-
in one of the existing agencies, then elevate the status of this group
to a level appropriate to our new challenges.
In the wake of the attacks on America on September 11, we have
begun to look for vulnerable areas in our society. The safety of our
food supply is a legitimate subject for inquiry, but under that mi-
croscope, it is clear that now when additional funds are needed to
ensure food security, we can ill afford the current systems lack of
coordination and the resulting waste of resources. Should a crisis
arise, either real or manufactured as a hoax, the deficiencies of our
current system would become glaringly obvious. For example, lets
assume a tampering hoax is staged. The public needs rapid reas-
surance from a credible source. Under current policy that could
easily involve multiple government agencies.
Since it is rare that a single agency has complete jurisdiction
over the entire scope of a major food safety problem, it has been
our experience that none of the agencies step forward in times of
crisis. It becomes impossible to find a spokesperson who can rap-
idly clarify the facts and reassure the public. Far more typically,
the public is faced with a lengthy delay while our overlapping bu-
reaucracies creep into some sort of action, culminating eventually
in a message of reassurance to the public.
To the issue of whether a coordinator would be enough to oversee
the existing agencies, we have an open mind on that, but we are
doubtful. Although some improvements could certainly be made,
there would still be overlapping jurisdictions and gaps.
Let me emphasize that none of this is due to the lack of skill or
dedication of those working within our various food safety agencies.
Quoting from the 1998 report of the commission to ensure safe food
from production to consumption, These are dedicated, capable peo-
ple, but they operate within an institutional framework that is out
of date and poorly designed to accomplish the critical goals that
food safety regulation in this field must achieve. The increasing
complexity of food production and delivery and the exploding inter-
nationalization of the U.S. food supply impose added pressures on
the Federal regulatory apparatus which was constructed in similar
times.

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Our FMI board of directors is open to other solutions that would


improve food safety oversight; however, we find it difficult to come
up with a simpler or more direct approach than designating a sin-
gle food safety agency. Thank you, Mr. Chairman and Members of
your Subcommittee, for the opportunity to speak with you today on
behalf of the members of the Food Marketing Institute.
Senator DURBIN. Thanks, Mr. Hammonds.
I would like to ask Mr. Cady and Mr. Molpus a question, because
from your testimony you appear to be skeptical of this notionI
guess that is a kind way of putting it, but let me just ask you this,
Mr. Cady, first: Do you agree that what ever food safety inspection
standard we have, it should be based on science?
Mr. CADY. Well, coming from a science organization, sir, the an-
swer is obviously yes. It needs to be based on science. It needs to
be risk-based. It needs to be properly budgeted for, which we have
not done over the years, especially in the FDA arena. It also needs
to be one that has a policy that emanates from science and risk as-
sessment, that is permeated throughout a unified food safety sys-
tem.
Senator DURBIN. Do you think our current system is based on
science?
Mr. CADY. I believe that the majority of our system is currently
based on science, but I caution that I do not believe we have gotten
far enough into the risk-assessment arena, where we can make bet-
ter use of the resources that we do have available. But I think the
science that is done by the agencies has improved tremendously
over the years and I think that the agencies coordinating activities
are making it even better.
Senator DURBIN. Can you then tell me the scientific basis for
daily inspections at the U.S. Department of Agriculture and quad-
rennial inspections through the Food and Drug Administration?
Mr. CADY. Well, I think, again, if you look at the risk involved
in the Department of Agriculture inspectionsand there are his-
toric issues, sir, that I am not saying we cannot take care of and
that the department could not make betterbut there are historic
issues based on animals that are being processed. Eighty percent
of my members food, however, is not regulated by FSIS, and so you
look atMr. Jacobson even mentionedsomebody who is making
a high-acid tomato product in Ohio, as an example. Is that the
same as some other product that perhaps has more risk than that
does? I think we have not made good use of that particular tool in
the risk-assessment area.
Senator DURBIN. You have made several points and I do not
want to blend them together. I am trying to keep them separate.
The point about funding, adequate inspection and the like is cer-
tainly one that no one argues with, I do not believe. But I do be-
lieve that Dr. Jacobsons initial point is the important one here.
The current system is not based on science. The current system is
so disparate in terms of the application of inspection, for example,
that it is hard for me to rationalize why daily inspection of agri-
culture through the Department of Agriculture, Poultry, and Meat
makes sense, but inspection once every 4 or 5 years through the
Food and Drug Administration still makes sense.

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I have to tell you that I think what drove the USDA into daily
inspection was not the wisdom Mr. Molpus refers to, but Upton
Sinclair scared Americans into finally initiating some sort of a Fed-
eral responsibility for inspecting meat. If you ever read it, as most
of us have, you can understand why. Chicago has changed a lot,
incidentally, since the book was published. But, there just is not
any consistent science here.
Mr. CADY. I disagree, of course, with Mr. Jacobson on that. I
think the science is there. I am not sure when you get into the in-
spection systemwhat I understand you are saying isI think the
science is there, how it is carried to the inspection system, through-
out the inspection system, I guess is what your question is. Again,
if you have limited dollars and you have limited inspectors, you
have to go to a risk-based system, and that makes better use of
your resources, and we have not done that fully.
Senator DURBIN. You said in your testimony no additional au-
thority is necessary. Now, that is a very broad statement in light
of what we just heard from former Secretary Glickman
Mr. CADY. No, I was talking about over the ports and that par-
ticular area. I do not believeagain the lawyers have to argue this
out and I am not a lawyer, but from what our discussions have
been on this with lawyers, we believe that they can do what they
need to do today at the ports in order to beef up security.
Senator DURBIN. Lets go to a specific point then, so I can have
your testimony on the record. Former Secretary Glickman has
noted the fact that the agencies, USDA and FDA, do not have au-
thority today to deal with products that have been subject to epide-
miological contamination as opposed to pathogen. Do you believe
that the law should be changed so that they have that authority?
Mr. CADY. I think we have to look at those authorities and we
have to decide whether or not that is good for the system and good
for the whole food safety system. Please remember that the indus-
try spends millions and millions of dollars a year on food safety
systems of their own and we get into these situations such as civil
and monetary penalties, and criminal penalties, which exist today
for adulterated food. The question I have always had is that when
somebody goes outand this has happenedand makes a bad deci-
sion on shutting down a plant under a mandatory system, lets say,
what recourse does that particular plant or company have if the de-
cision is not correct? Essentially they are out of business. So, my
point is, it needs to be looked at. If they need authority in that par-
ticular area, then I am not against opening it up and talking about
it at all.
Senator DURBIN. Well, I would like to ask Mr. Molpus. You said
something in your testimonyit is part of the record nowand it
says that the current systemyou were referring to the current
systemreflects the informed judgment of law makers and govern-
ment officials over many decades, that different sectors of the food
supply present different challenges and thus, call for a different in-
spection and regulatory system. That seems to suggest that there
is some sort of divine plan here behind our food and safety inspec-
tion, or at least a coordinatedlets use that, a coordinated think-
ing and wisdomyou used the word wisdombehind our current

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system. Do you find wisdom in a system that treats an opened-


faced sandwich different than a closed sandwich?
Mr. MOLPUS. Well, with all due respect, Mr. Chairman, the Con-
gress must find that to have some wisdom. What I think has been
said here numerous times todayand I think it bears repeating
many of these issues flow from the fact that the Congress, in pass-
ing the statutes that created the inspection systems for food in
total, created different statutes with different laws that affect dif-
ferent segments of the industry. Congress created, as you elo-
quently alluded to, the Meat Inspection Act after Upton Sinclairs
in The Jungle. As you may remember, I was president of the
American Meat Institute in the first life where we met, and that
is a different statute than the one that is dealing with other foods.
And to your point with the questioning of Mr. Cady, the intensity
that we want in a meat plant every day, intensive inspection that
is mandated by lawthat can be changed by the Congress. It will
not be changed by bringing all the agencies together. We have a
lot of fun poking fun at pizza. Pizza has been one of the most suc-
cessful products in the history of the American food industry. It
has managed to survive this quagmire of government inspection. It
has been a tremendous success with consumers and in the indus-
try, and combining the agencies, putting all the agencies in one
house, would not solve that pizza problem. It would not solve, I do
not think, the open-faced sandwich problem. If there is any point
that needs to be made here today, it is underlying statutesand
that is what I was trying to make in my testimonyit is under-
lying statutes separately passed by the Congress that drive dif-
ferent types of approaches to inspection.
Senator DURBIN. That is why we are here today, those under-
lying statutes and that so-called wisdom that brings us to this
point where we are so embarrassed today by what we have. Let me
ask you, as I have asked Mr. Cady, Secretary Glickman makes the
point about epidemiological contamination. Do you think the FDA
and USDA should have authority when it comes to epidemiological
contamination as it does for pathogens?
Mr. MOLPUS. Well, essentially we are not regulated by USDA. I
have seen nothing that makes me think FDA needs that authority
or I did not hear them say they desired that authority. I do not
think we have had those kind of issues with the type of foods that
FDA regulates.
Senator DURBIN. Mr. Molpus, based on Dr. Schwetzs testimony,
I do not see how we can take that position. He has said in his testi-
mony that food is a medium for bioterrorism. I do not want to cre-
ate panic, but I want to be realistic. I do not want something to
happen tomorrow and hear, Why didnt you even talk about it in
Congress the day before? That is why I think that what the Sec-
retary has suggested is a reasonable suggestion, to give these agen-
cies the authority to deal with bioterrorism. God forbid we ever
need it, but they should have that authority. Should they not?
Mr. MOLPUS. Well, I will tell you this, Senator, they have never
talked to us about needing that authority that I am aware of. It
has never been an issue in the regulation of the foods that I rep-
resent. If it is an issue, then we are willing in these particular
times to sit down with the agency and rediscuss and reevaluate

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some of these legislative needs. They may be on an emergency


basis, some things we need to do. Whether that is one of them or
not, I could not tell you today.
Senator DURBIN. I think that is a reasonable position. Dr.
Jacobson, could you comment on that suggestion from Secretary
Glickman about the epidemiological protection?
Mr. JACOBSON. I am not sure what the underlying laws here are,
but my sense was that Secretary Glickman was saying if a food is
linked to health problems without proof of a particular organism,
then the government should be able to take action. And I think
that it is patently obvious that government should be able to take
action, because it might take weeks or months to track down a par-
ticular organismlike we saw with mad cow disease. It is a new
organism in our experience.
I would like to step back, if you do not mind. I am very dis-
appointed that the industry is not supporting the best possible
food-safety system. Yes, we need changes in the statutes and we
need reorganization, and I think former Secretary Glickman was
very clear about this. Neither by itself will work. We need to do the
two things sequentially or at the same time, but move in that di-
rection. If there were a tragedy where you have FDA and FSIS
fighting over whether the beef broth was 1 percent or 3 percent
beef, and so we do not know who is going to regulate it, it would
be a crying shame that actions were not taken because we had this
crazy statutory patchwork and bureaucratic mess. And if we did
have that tragedy, I think the food industry and opponents of ac-
tion in Congress would feel extraordinarily embarrassed.
Senator DURBIN. I think you are right. I am going to turn it over
to my colleague here, Senator Voinovich, and I will just make one
comment. I find that there is a resistance in some areas to the
changes which we are discussing. When it comes to government
agencies, there is only one thing that can bring someone who is in-
volved in this area around to my point of view and that is leaving
civil service. Once they are out of the private sector, they seem to
think that this is nothing but the best idea in the world.
Senator Voinovich.
Senator VOINOVICH. In the high-risk series update published
January 2001 by the General Accounting Officeand by the way,
they put human capital as a new high-risk areathey cite the De-
partment of Agricultures organizational culture, especially in its
role of overseeing food safety, as an example of an agency that
faces human capital challenges. Although food safety is not deemed
a high-risk issue, GAO has listed food safety oversight as one of the
major management challenges facing the Department of Agri-
culture.
GAO has explained that they feel the problem is not isolated to
the Department of Agriculture, but rather than identifying it as a
governmentwide problem, they chose to focus on the USDA. Now,
these problems have been around a long, long time. I would be in-
terested, Mr. Cady, and Mr. Molpus, what suggestions have your
organizations made over the years to these agencies, and what kind
of response have you received? I know you mentioned, finally, that
they funded the budget.
Senator DURBIN. This year.

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Senator VOINOVICH. This yearbut what recommendations have


you made and what kind of response have you gotten back over the
years, and what makes you think that now that we have an addi-
tional challenge that things are going to be different in terms of co-
ordination between the agencies and the commitment of resources
that need to be made? You mentionedI think Mr. Molpus, you
talked about consumermore resources; science and research co-
ordination; regulated, updated products and so forth. They are all
out there, and what is really being done? And how do you respond
to the fact that it has not been done and it does not require some
new way of accomplishing this issue?
Mr. MOLPUS. Senator, I think the FDA has made some consider-
able progress. I think over the last 4 years there has been a signifi-
cant or a noticeable decrease in the diagnosed cases of Salmonella
and Listeria. They have set forth some targets for 2005, which, in
reduction of these foodborne illnesses, they have almost reached
those targets already. There is continual innovation and progress.
I think what we are saying from industry is, it could be faster.
There could be more resources. They have been a resource-starved
agency, and with additional resources and the application of better
and improved science and technology, and given that we all say
that they are best in the world, I think they can get the job done
without going through the distraction of a structural reorganiza-
tion.
Senator VOINOVICH. But the fact is, they have not gotten the job
done. It is an issue of priority in terms of somebody coordinating
it and saying that this is a national problem.
I was interested in Mr. Hammonds testimony. You are saying
that we have had outbreaks. Why dont you share with me an ex-
ample of a couple of them where you could not get somebody to
step up to the table and clarify it? If we had something like this
right now, how would we deal with it in a way that the public
would feel confident that something was happening, Mr. Ham-
monds?
Mr. HAMMONDS. Well, almost any of the outbreaks would serve
as an example. Perhaps the clearest was our Chilean grape situa-
tion, which in hindsight turned out not to be a huge problem, but
at the time it was impossible for us to find someone from the gov-
ernment willing to step forward and reassure the public. But retail-
ers and T.V. news cameras can always find a supermarket. Retail-
ers turned out to be the ones out front on that, and the ones doing
as best we can to give the public reassurance.
I would point out that in the middle of the food distribution sys-
tem, groups tend to be regulated by single agencies or have very
clear lines of authority. When you arrive closer to the consumer
and you get into the supermarket, one way or another we are regu-
lated by everyone. So we see the kinds of overlaps, the kinds of
gaps and therefore, the kinds of time we waste trying to get a cred-
ible analysis of the situation and a reassuring statement out of the
government. So, perhaps we deal with a more difficult problem
than those earlier in the distribution system, but it is a problem.
Senator VOINOVICH. The manufacturers are saying the system is
OK, and those of you that are out there, retailers, say this system
is not working, and youre concerned that you get the wrong infor-

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mation out there and you cannot move in on it and this will have
a devastating impact on your businesses. People stop buying what-
ever the case may be, and it just ratchets down. It is interesting
with the airlines, the enormous cascading that has gone on in this
country in other areas. Everyone is saying now, if you really want
to do something about the economy, get the planes flying and get
them up in the air and make people feel secure. One or two items
like this just haveit was the egg thing at one time and it just rip-
ples across. So, there seems to be a difference of opinion here be-
tween Mr. Molpus, Mr. Cady and you, Mr. Hammonds, and you are
all on the private sector side of this thing.
Mr. MOLPUS. It is rare that we disagree. The point that it goes
to we have a different relationship with the agencies than the su-
permarket industry and a lot of this goes to the view and experi-
ence that we have had with the agency versus someone elses expe-
rience. We have not had the experience of having indecisiveness
about who is in charge during the time of any sort of a food safety
crisis that we have dealt with. We are looking at throwing out
some atypical examples and coming to conclusions, rather than
looking at the vast majority of incidents. It is fairly clear. You can
talk about the pizza issue, but it is fairly clear that the products
are at USDA and that they deal with them through the system and
the products that are at FDA and that they deal with them.
Mr. JACOBSON. Do not forget the $100 billion worth of products
whose labeling and safety is overseen by the Bureau of Alcohol, To-
bacco and Firearms. The Treasury Department does not put this at
the top of its list when you are asking the Secretary for what the
issues are. We have seen cases where beer was contaminated with
nitrosamines, which are cancer-causing substances. Wine and liq-
uors were contaminated with urethane, another cancer-causing
substance, and these substances developed during the manufac-
turing processes. Wine contains sulfites, which is deadly to a small
percentage of the population. It causes acute reactions.
When we went to the Bureau of Alcohol, Tobacco and Firearms,
they did not have the foggiest idea of what to do about these
things. It took a fair length of time before they learned how to co-
ordinate with the FDA. That may be at the extremes, but we are
talking about a lot of product being consumed that falls largely out-
side the ambit of FDA or USDA. That is something I think should
be expressed in your bill. But, I think Mr. Molpus is right. Usually
things work out fine and we do have a pretty safe food supply in
this country. Most people do not die of food poisoning, just 5,000
a year. Is that OK? We need to be concerned about where the prob-
lems are and maybe it is one-tenth of 1 percent of all the food or
decisions that are being made, but that is where the problems are
going to occur. That is what we should anticipate and prevent.
Mr. CADY. I would like to make a couple of comments, if I could.
One, my association is responsible for working with our companies
relative to recalls when they occur, and in the 14 years that I have
been associated with this, I have never had a problem determining
or having the agencies determine as to who is responsible or in
charge of that particular recall. So, I can just say that I have not
seen that fall through the crack in terms of responsibility.

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You made a couple of statements earlier, both of the Senators


did, relative to why doesnt this thing work then, if we think it is
such a great system. I think it is like anything else. If you have
two companies that merge, there is a CEO that drives the issue in
terms of bringing those two companies together, not only in terms
of their culture, but also in terms of their production issues, mar-
keting issues. What has not occurred in the government aspect of
managing this system, in terms of coordination and communica-
tion, is the accountability taken over by, and I start at the Sec-
retary level, to make sure that the coordination and the commu-
nication exists. What we really do is, we usually talk about it at
these type of hearings and the Secretaries may talk about it, but
it gets pushed down to the working level agencies that actually do
it, and it is harder to do that.
I think that we need my suggestion, in terms of trying to clear
up some of this pizza issue, which I love to hear aboutI do not
think it is a food safety issue. I think it is a department issue, in
terms of who should be responsible for pizza, which is a great prod-
uct, but it is not a food safety issue. But, I think from that you can
get a lot more out of this system. Are there some legislative things
that need to change? Probably. Are there some department respon-
sibilities that could be put together? Probably. Are there better
ways we can do risk assessment? Certainly. But, I think people
have to focus on it and carry it through, and I do not believe in
my tenure in this town that that has occurred.
Senator VOINOVICH. Well, the question I have is, and I challenge
you today, is to come up with those recommendations about the
things that you think need to be done in terms of coordination, in
terms of resources and some of the things that you have talked
about now and in your testimony.
Mr. CADY. We will do that.
Senator VOINOVICH. And, to see if you can get that kind of atten-
tion given to itI have, and I have been here a short timebut,
getting agencies to coordinate their activity around here is very,
very difficult.
Mr. CADY. Well, let me add that we brought up the EPA a little
while ago. One of the concerns I have with going to a single food
agency from a government bureaucracy perspective is that I look
at the EPA, and after 30 yearsand you go back to see what it was
supposed to do and how much was supposed to be encompassed in
thatand I can tell you that in my relationships with the EPA as
a new agency now of 30 years, the coordination and communication
amongst and between is not particularly goodI am not sure how
it was before then. I was not here at that timebut it has not been
that terrific because we have a new agency.
I also think we need to talk about food safety from a political
perspective, Mr. Chairman. Food safety cannot be politicized and I
am concerned about what a single food agency, at the end of the
day, headed by a politically appointed administrator, would amount
to, and I think that
Senator VOINOVICH. If your analogizing it to EPA, I agree.
Mr. CADY. That is my point, sir. That is how I feel about it.
Senator DURBIN. I might just say in defense of the EPA
Mr. CADY. OK, Senator.

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Senator DURBIN. The standards for air and water quality over
the last 30 years dramatically improved. We focused our resources
on a mission and we really achieved a lot. There is more to achieve
and you will find, I think, some bureaucratic tangles in virtually
every single agency.
Mr. Cady, you talk about a CEO driving this kind of combina-
tion. We may have that in place. As quoted earlier, Presidential
candidate George W. Bush was in favor of this concept that we are
talking about today and I have spoken to him about it. He under-
stands it then and now, and I think in the context of September
11, understands there is a new dimension to it. I might also add,
as I did earlier, I think Governor Ridge is going to have some voice
in this, as he should, to talk about whether or not this is part of
the security of our Nation. I trust Tom Ridge a lot, because I have
known him for so long, and I hope as soon as he can get his head
above water that I can talk to him about this, too.
Mr. CADY. I think you will see that happen, and food security
and food safety, I think, is going to be a large part of his focus once
he gets organized.
Senator DURBIN. Dr. Chalk, before we break here, let me go back
to some of the points you have made, and one of them I felt was
particularly important when it came to our agricultural exports
being such a large part of American food processing in agriculture.
I think the point you made here is the share of products sold over-
seas is more than double that of other U.S. industries. So one of
the points I made early on was the hope that this is not just a
monologue in the United States, but becomes a dialogue with other
countries, so that we can start establishing standards one to the
other, with some hope that we can harmonize the way we produce
food so that it is safe and secure as it crosses borders. I do not
know if that is the point that you are alluding to as well.
Mr. CHALK. Absolutely, and I think that any initiatives that are
taken on that basis are overdue and only to the good. One only has
to look at the numerous examples of countries that have been af-
fected by major animal disease outbreaks: Taiwan, the United
Kingdom recently, Argentina this year, to catalog the enormous
economic destruction that can be wrought on those countries, not
only in the term of immediate protective embargoes, but the ripple
effect that can go on for many years. Taiwan is still suffering from
the 19901997 outbreak, and actually has not recovered. So, I
think that any institution of cross-border standardization has to be
part of the overall solution, particularly in a globalized world.
We are no longer dealing with countries that can view what oc-
curs within their own borders stopping at that border. We are in
an international system. Where the trading of commodities is more
global and rapid than ever. Therefore, it is incumbent that we do
have some sort of globalized or at least regionalized standardiza-
tion across borders.
Senator DURBIN. Can you imagine that first meeting with the EU
when we sit down and say, in our wisdom, based on our view of
science, we think that a whole egg should be inspected perhaps
once every day and that a broken egg inspected once every 4 years?
When you get down to it, there is no way we can say that with a
straight face and that reflects the current system in America.

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The last question I have for you, Dr. Chalk, is you make a point
here about confidence in government, and I think what has hap-
pened in Europe is instructive of where we are today. I think there
are some parallels here, because in Europe, government did not re-
spond to a very serious concern of consumers, whether it was BSE
or antibiotics in animal feed or some of these other concerns that
people had, GMOs for that matter, and as a result the stage was
taken over by people who did not bring science to the party. They
brought a lot of fear to the party. As a result, I think, many of
these government agencies were discredited in Great Britain and
in the European Union. Now they are struggling to re-establish
their credibility.
Well, we have a new world, too. We have a new challenge where
I think consumers are going to look to us. What have we learned
from September 11 based on some of the things we have heard in
the testimony at the hearing today? What are we going to do, as
a government, to respond to what people are legitimately concerned
about? Sadly, bioterrorism is one of those that is back on the stage.
I hope we have a credible governmental response so that people be-
lieve they can have confidence, not only in their government, but
equally important, or more important, in the safety of our food sup-
ply.
I will just close as I started. We have the safest food supply in
the world. It bears repeating. We can do better and what we have
heard today are, I think, some suggestions and examples of ways
that we can improve it. I want to thank all those who attended. I
want to announce that the record of the hearing will remain open
for 1 week for Subcommittee Members to submit statements or ad-
ditional questions for witnesses.
I thank my colleague, Senator Voinovich, for joining me.
Senator VOINOVICH. Can I just make one last comment?
Senator DURBIN. Certainly.
Senator VOINOVICH. I was quite pleased to hear that the Depart-
ment of Agriculture and the Food and Drug Administration are
working together with the administration. That was very com-
forting to me. I would hope that those of you who represent the in-
dustry would be making your recommendations also about things
that you see that are out there that we ought to be concerned
about, because you are actually out on the front lines dealing with
these problems. I think your input would be very, very important
and I am sure well-received.
Mr. CADY. We have a process going now just doing that in terms
of the alliance that are running, in terms of information, working
with the government, working with both agencies, so that the com-
munication is flowing both ways. And I think it is going to work
well, sir.
Mr. MOLPUS. The conversations with FDA are daily.
Senator VOINOVICH. Good. Thank you.
Senator DURBIN. Thank you, witnesses. I thank you, Senator
Voinovich. The Subcommittee stands adjourned.
[Whereupon, at 3:20 p.m., the Subcommittee was adjourned.]

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